Guideline: Physical Therapist Clinical Practice Guideline For The Management of Individuals With Heart Failure

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Clinical Practice

Guideline
M.J. Shoemaker, PT, DPT, PhD,
Department of Physical Therapy, Grand Physical Therapist Clinical Practice
Valley State University, 301 Michigan
NE, Suite 200, Grand Rapids, MI 49503
(USA). Dr Shoemaker is a board-
Guideline for the Management of
certified clinical specialist in geriatric
physical therapy. Address all Individuals With Heart Failure
correspondence to Dr Shoemaker at:
[email protected]. Michael J. Shoemaker, Konrad J. Dias, Kristin M. Lefebvre, John D.
K.J. Dias, PT, DPT, PhD, Physical Heick, Sean M. Collins
Therapy Program, Maryville
University of St Louis, St Louis,
The American Physical Therapy Association (APTA), in conjunction with the Cardiovascular

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Missouri. Dr Dias is a board-certified
clinical specialist in cardiovascular and Pulmonary Section of APTA, have commissioned the development of this clinical practice
and pulmonary physical therapy. guideline to assist physical therapists in their clinical decision making when managing patients
K.M. Lefebvre, PT, PhD, Department of with heart failure. Physical therapists treat patients with varying degrees of impairments and
Physical Therapy, Concordia University limitations in activity and participation associated with heart failure pathology across the
St Paul, St Paul, Minnesota. Dr Lefebvre continuum of care. This document will guide physical therapist practice in the examination and
is a board-certified clinical specialist in treatment of patients with a known diagnosis of heart failure. The development of this clinical
cardiovascular and pulmonary physical practice guideline followed a structured process and resulted in 9 key action statements to
therapy.
guide physical therapist practice. The level and quality of available evidence were graded
J.D. Heick, PT, DPT, PhD, Department based on specific criteria to determine the strength of each action statement. Clinical algorithms
of Physical Therapy, Northern Arizona
were developed to guide the physical therapist in appropriate clinical decision making. Physical
University, Flagstaff, Arizona. Dr Heick is
therapists are encouraged to work collaboratively with other members of the health care team
a board-certified clinical specialist in
in implementing these action statements to improve the activity, participation, and quality of life
orthopaedic physical therapy, neurologic
physical therapy, and sports physical
in individuals with heart failure and reduce the incidence of heart failure-related re-admissions.
therapy.
S.M. Collins, PT, ScD, Physical Therapy
Program, Plymouth State University,
Plymouth, New Hampshire.

[Shoemaker MJ, Dias KJ, Lefebvre KM,


Heick JD, Collins SM. Physical therapist
clinical practice guideline for the
management of individuals with heart
failure. Phys Ther. 2020;100:14–43.]

© 2020 American Physical


Therapy Association
Accepted: June 10, 2019
Submitted: January 13, 2019

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article at:
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14 Physical Therapy Volume 100 Number 1 2020


Heart Failure Clinical Practice Guideline

P hysical therapists play a fundamental role in the examination, health care expenditures.7 Increasing attention is being
placed on hospital readmissions for patients with HF due
evaluation, and treatment of patients with heart failure (HF,
formerly congestive heart to the substantial burden it places on patients and
failure and chronic heart failure, or CHF) throughout the payers.7,8
continuum of care. Empirical evidence on the
effectiveness of a variety of rehabilitation treatment Readmission can operationally be defined as simply being
interventions for patients with HF continues to evolve. admitted to the hospital within a specified period following
Physical therapist interventions including education, an index (first, incident) admission. The costs associated
resistance exercise, aerobic exercise, inspiratory muscle with HF readmissions are nearly 31 billion dollars
training, electrical stimulation, and behavior modification annually.9 This total includes the cost of health care
strategies can positively influence functional capacity, services, medications, and missed employment.9 These
strength, and quality of life in patients with HF, and could costs have been rising at an alarming pace, prompting the

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contribute to decreased hospital readmissions.1 Centers for Medicare and Medicaid Services (CMS) to
implement the HF Readmissions Reduction Program in
HF is a chronic and progressive condition in which 2012.10 According to the CMS final rule, readmission within
the heart loses the ability to efficiently pump blood to the 30 days of discharge from the hospital for patients with HF
extremities, organs, and skin.2 During episodes of acute would result in an economic penalty to the reimbursement
decompensation, physiologic requirements for blood and of that hospital system. The Readmission Reduction
oxygen delivery are unmet, resulting in a clinical syndrome Program has prompted medical professionals and
with many signs and symptoms. The array of symptoms rehabilitation specialists to make changes in care delivery
noted in patients with acute decompensated HF is due to reduce readmissions.
to a complex series of events involving pathophysiological
and compensatory responses to cardiac muscle Considering the escalating readmissions and health care
dysfunction.3 These hemodynamic, neuroendocrine, costs associated with HF, the American Physical Therapy
inflammatory, and autonomic pathophysiological and Association (APTA) charged the Cardiovascular and
compensatory responses negatively impact multiple Pulmonary Section with developing a clinical practice
organ systems, including the lungs, kidneys, liver, and guideline for the management of patients with HF. Clinical
skeletal muscles.3,4 It is important to note that the practice guidelines (CPGs) utilize expert analysis of
deconditioning effects of HF on skeletal muscle function available data on the risks and benefits of procedures
are compounded by these pathophysiological and documented within the literature. CPGs provide clinicians
compensatory changes, resulting in catabolic with a set of ideal management strategies for use in
and histological changes.4 In light of the complexity individual patients. The present CPG provides physical
of HF, the challenges of achieving long-term physiological therapists with recommendations based on the highest
stability, the severity of signs and symptoms, and level of available evidence involving physical rehabilitation
the involvement of multiple organs, patients with HF are of the patient with HF. The aim is to provide physical
likely to have substantial limitations to physical function, therapists with evidence-based recommendations that
reduced health-related quality of life (HRQL), and require assist in improving functional capacity and HRQL and
multiple hospital admissions and extensive medical care.5 reducing hospital readmissions for individuals with HF.

Physical therapists can utilize the key action statements in


Background and Need for a Clinical the present CPG in clinical decision making by reviewing
Practice Guideline in Heart Failure the range of acceptable approaches to the examination
According to the American Heart Association, the and treatment of HF presented in this paper. However,
prevalence of HF for adults over 20 years of age is rapidly they are cautioned that although these key action
increasing. Recent statistics show that the prevalence of statements describe practices that meet the needs of many
HF increased nearly 20% from 5.7 million (2009–2012) to patients, they are unable to address each unique situation
6.5 million (2011–2014).2 One in 9 deaths in 2009 included of an individual patient. Therefore, therapists may deviate
HF as a contributing cause and half of people who develop from these guidelines as appropriate to meet the needs of
HF die within 5 years of diagnosis.6 Fifty-three percent of the individual patient.
hospitalizations included patients with reduced ejection
fraction and 47% with preserved ejection fraction, with
black men comprising the highest proportion with reduced Pathophysiology of Heart Failure
ejection fraction (70%) and white women comprising the HF is most commonly caused by cardiac muscle
highest proportion of preserved ejection fraction (59%).2 dysfunction. Cardiac muscle dysfunction is a general term
describing altered systolic and/or diastolic activity of the
myocardium that typically develops due to underlying
Hospital readmission in patients with HF is currently a abnormalities within the structure or function of the
focus of national interest due to its association with high myocardium. Hypertension and coronary disease,

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Heart Failure Clinical Practice Guideline

particularly myocardial infarction, were thought to be the output).12 With HFpEF, LVEF is unaltered and remains
primary causes of cardiac muscle dysfunction. However, a between 55% and 75%.12 To date, efficacious therapies for
variety of other pathophysiologic causes have more patients with HFpEF are less documented in the literature.
recently become increasingly responsible for Therefore, the reader will note that the key action
cardiomyopathy and subsequent HF, including diseases of statements in the present CPG are primarily directed
the myocardium, pericardium, endocardium, heart valves, towards patients with HFrEF, and limitations in evidence
coronary vessels, as well as from toxins, poorly managed for those with HFpEF are discussed where appropriate.
systemic hypertension, pulmonary and pulmonary and
vascular diseases, and metabolic disorders.11
Classification of Severity of Heart Failure
The subtypes of HF are categorized from both a structural
The American Heart Association/American College of
and functional perspective. Structural HF may include left-

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Cardiology (AHA/ACC) and New York Heart Association
sided, right-sided, or biventricular dysfunction. Left-sided
(NYHA) have created 2 complementary HF classification
HF occurs with left ventricular insult. Pathology of the left
systems of HF severity from both structural and functional
ventricle reduces cardiac output, leading to an
perspectives.2,15 From a structural perspective (Tab. 1), HF
accumulation of fluid within the left atrium with subsequent
is staged based on the extent of structural damage to the
pulmonary congestion and pulmonary edema, which is
myocardium and represents irreversible progression of
augmented by renal-mediated fluid retention. Pulmonary
disease severity. For example, if a patient moves from
edema produces the 2 hallmark pulmonary signs of
Stage A to B, then it is not expected that the patient would
dyspnea and cough.12 Right-sided HF occurs following move back to Stage A.
insult to the right ventricle. Pathology of the right ventricle
is commonly caused by conditions that elevate pressures
The NYHA functional classification (Tab. 1) delineates
within the pulmonary arterial system.13 With right-sided HF,
four classes of HF based on symptoms with physical
reductions in right ventricular cardiac output results in activity. NYHA classes represent variable patient
venous congestion, producing the 2 hallmark peripheral symptoms that vary bi-directionally where there can be
signs of jugular venous distention and peripheral edema, progression and regression depending on a patient’s
as well as ascites and pleural effusion. Finally, biventricular current state. NYHA classes I to IV gauge severity of
failure occurs when both ventricles fail. Patients symptoms in individuals with structural heart disease
experiencing an acute exacerbation of heart failure typically (AHA/ACC stages B, C, and D).
present in biventricular HF, where left-sided heart failure
results in pulmonary vascular congestion, right ventricular
overload, and ultimately systemic venous congestion. Recognition of Acutely
These patients typically present with pulmonary and Decompensated Heart Failure
peripheral signs and symptoms of fluid overload including In addition to the AHA/ACC stages and the NYHA
dyspnea, cough, jugular venous distention, and peripheral functional classification system, the reader will find the
edema. term stability used throughout this document. In a patient
with HF, stability first requires being compensated
Functional HF may be due to either systolic or diastolic (AHA/ACC stages A–C and NYHA functional
dysfunction of the left ventricle, and is referred to as HF classifications I–III). Compensation also requires that the
with reduced ejection fraction (HFrEF) or HF with patient not currently be exhibiting the aforementioned
preserved ejection fraction (HFpEF), respectively. Systolic pulmonary and venous congestion-associated signs and
dysfunction in HFrEF refers to a decrease in myocardial symptoms. Stability refers to the probability of staying
contractility characterized by compromised contractile compensated. A patient who is stable can participate,
function of the ventricles resulting in reductions in ejection perform activities, exert with appropriate changes in vital
fraction, stroke volume, and cardiac output.14 Patients with signs without signs of exercise intolerance, and then return
systolic dysfunction typically present with a compromised to baseline within a reasonable period of time.16
left ventricular ejection fraction (LVEF) less than 40%.11
Randomized clinical trials have mainly enrolled patients Felker and colleagues define acute decompensated HF as
with HFrEF and it is primarily in these patients that the presence of new or worsening signs/symptoms of
efficacious therapies have been demonstrated to date. dyspnea, fatigue, or edema that lead to hospitalization or
Diastolic dysfunction, also known as HFpEF, is unscheduled medical care (doctor visits or emergency
characterized by compromised diastolic function of the department visits).17 The hallmark signs of
ventricles.12 With this condition, the ventricles cannot fill decompensation are related to increased congestion and
adequately during the relaxation (diastolic) phase of the increased ventricular filling pressures. Common signs and
cardiac cycle. The impaired ventricular filling (reduced end symptoms of HF exacerbation include fatigue, dyspnea,
diastolic volume [EDV]) decreases the volume of blood edema (pulmonary and peripheral), weight gain, and chest
ejected with each contraction (stroke volume) and the pain. It is important for clinicians to assess signs and
overall volume of blood ejected per minute (cardiac symptoms of HF at every visit. Regular monitoring of

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Heart Failure Clinical Practice Guideline

Table 1.
American Heart Association/American College of Cardiology (AHA/ACC) Stages and New York Heart Association (NYHA)
Functional Classes of Heart Failurea

AHA/ACC Stage Description NYHA Class Description


Stage A At high risk for developing HF. No identified N/A
structural or functional abnormality, no signs
or symptoms of HF.
Stage B Structural heart disease that is strongly I No limitation in physical activity; ordinary physical activity does
associated with the development of HF but not cause fatigue, palpitations, or dyspnea.
no signs and symptoms of HF.
Stage C Symptomatic HF, associated with underlying I No limitation in physical activity; ordinary physical activity does

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structural heart disease. not cause fatigue, palpitations, or dyspnea.
II Slight limitation of physical activity; comfortable at rest but
ordinary activity results in fatigue, palpitations, or dyspnea.
III Marked limitation of physical activity; comfortable at rest but
less than ordinary activity results in fatigue, palpitations, or
dyspnea.
IV Symptoms at rest; unable to do any physical activity without
symptomology.
Stage D Advanced structural disease with marked IV Symptoms at rest; unable to do any physical activity without
symptomology at rest despite maximal symptomology.
medical therapy.

a HF = heart failure; N/A = not applicable.

Table 2.
Definitions of Zone Colors Associated With Clinical Manifestations and Physical Therapist Recommendationsa

Zone Color Signs and Symptoms Physical Therapist Recommendations


Green zone • No shortness of breath Continue activity and therapy as tolerated.
• No swelling
• No weight gain
• No chest pain
• No decrease in your ability to maintain your activity level
Yellow zone • Weight gain of 2–3 lbs in 24 hrs Symptoms may indicate an adjustment in medications and
• Increased cough therefore warrants communication with the physician.
• Peripheral edema: increased distal extremity swelling
• Increase in shortness of breath with activity
• Orthopnea: increase in the number of pillows needed
Red zone • Shortness of breath at rest Symptoms indicate overt decompensation and an immediate
• Unrelieved chest pain visit to the emergency department or physician office.
• Wheezing or chest tightness at rest
• Paroxysmal nocturnal dyspnea: requiring to sit in chair to sleep
• Weight gain or loss of more than 5 lbs in 3 days
• Confusion
aAdapted from https://innovations.ahrq.gov/qualitytools/red-yellow-green-congestive-heart-failure-chf-tool

signs and symptoms are necessary in evaluating a CPGs: the 2013 American College of Cardiology
patient’s response to exercise, signs of exercise guidelines,14 the 2006 Heart Failure Society of America
intolerance, and stability over time. Worsening of guidelines,18 the 2012 European Society of Cardiology
symptoms places the patient at risk of urgent guidelines,19 and the 2011 Canadian Cardiovascular
hospital admission and merits prompt medical Society Heart Failure Management guidelines.20 For this
attention. reason, recognition of decompensation is not a seperate
action statement in this CPG, but rather a fundamental
Recommendations in the present CPG for the physical element of examination that should be performed when
therapist in evaluating the symptomology of acute implementing any of the key action statements in the
decompensation have been developed from four prior document below.

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Heart Failure Clinical Practice Guideline

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Figure 1.
Algorithm for patient with heart failure evaluated by a physical therapist. AHRQ = Agency for Healthcare Research and Quality; ED =
emergency department; JVD = jugular venous distention; S3 = third heart sound.

To help physical therapists determine whether a patient is individuals with HF that are not medically compensated or
sufficiently stable to proceed with an intervention, we have for those who are medically compensated and have no
provided an algorithm to determine whether a patient is participation restrictions and are already physically active.

by guest on 13 April 2020


compensated (Fig. 1), which is based in part on the Red- Individuals with HF who have participation restrictions or
Yellow-Green CHF Tool developed by the Agency for are not physically active and do not have any activity
Healthcare Research and Quality (Tab. 2). The Tool is limitations on exam should be encouraged to participate in
divided into green (“all clear”), yellow (“caution”), and red some sort of physical activity. If an individual has an
(“medical alert”) zones. Identification of specific signs and activity limitation, the physical therapist should determine
symptoms within each zone can help physical therapists whether that individual can perform the activity that is
recognize when it is appropriate to seek emergency limited (eg, if the activity limitation is climbing stairs,
medical assistance. A second algorithm was developed to whether the person can climb stairs at all must be
help physical therapists determine which action statements examined). If the individual cannot perform the activity,
are most appropriate for a particular patient based on then the appropriate intervention should be utilized, and
participation, activity, endurance, and signs of exercise several of the key action statements can be considered. If
intolerance (Fig. 2). The algorithm in Figure 2 is based on the activity can be performed, endurance for the activity is
expert opinion by the Guideline Development Group (GDG) then considered, along with additional action statement
and was reviewed by the external stakeholders. The considerations.
available research reviewed, short of limiting itself through
inclusion and exclusion criteria to patients with medically Physical therapists should recognize the presence of HF
compensated HF, did not address specific examination- exacerbation and recommend prompt medical follow-up
based criteria for when any of the interventions reviewed when the patient is presenting with signs and symptoms
herein are appropriate. Based on this algorithm, physical of acute decompensation. To reduce further clinical
therapy may not be indicated for deterioration and subsequent hospital readmissions,

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Heart Failure Clinical Practice Guideline

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Figure 2.
Algorithm for patient with heart failure and signs of decompensation. ECG = electrocardiogram; ED = emergency department; PT =
physical therapist; S3 = third heart sound.

physical therapists are integral members of the selecting exercise interventions and their associated
interprofessional team assisting with early detection of HF training parameters in that consideration should be given
exacerbation and directing medical follow-up. Physical to self-efficacy, readiness for behavior change, patient
therapists should work within their health care systems to preferences, and individual constraints, which may improve
determine how these or similar algorithms for identification long-term exercise adherence.21–23 Approaches including
of HF exacerbation can be utilized within their specific motivational interviewing, transtheoretical model of
contexts and patient care environments. behavior change, and Bandura’s Social Cognitive Theory
in isolation or in combination may be used.22 Specific
techniques and strategies based in these approaches
Adherence to Exercise-Based Interventions include goal setting, positive feedback, facilitation of
Unlike research on exercise-based interventions in HF, the problem solving, learning by doing, role modeling,
evidence for interventions to improve exercise adherence supportive visits and phone calls, and caregiver
lacks a single meta-analysis due to a broad range of engagement.22–24
interventions and a broad range of measures, most of
which are self-report. This broad range of qualitative A construct related to exercise adherence is the translation
measurement, lack of objective measurement, and lack of of improved exercise capacity and performance into an
unifying conceptual framework precluded the present GDG increase in overall daily physical activity (ie, structured and
from developing a key action statement on exercise incidental physical activity).25 This is believed to be
adherence. However, a few observations about existing important in stopping the negative cycle of inactivity and
literature can be made to help guide clinicians when deconditioning.26 Similar to the literature on exercise

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Heart Failure Clinical Practice Guideline

adherence, the research on interventions to improve publications. Abstracts and full text (as necessary) were
overall daily physical activity lacks a consistent objective reviewed by at least 2 members of the GDG, with a third
measurement that allows meta-analysis and precluded the available should disagreement arise (no instances of
present GDG from developing an individual key action disagreement occurred). Meta-analyses, systematic
statement. However, it appears that exercise-based reviews, and clinical practice guidelines were reviewed for
interventions alone are insufficient for translating improved whether they specifically addressed the patients,
exercise capacity into increased overall daily physical interventions, comparisons, and outcomes of interest for
activity and should therefore include the same this CPG. Specifically, whether they: included adult
psychosocial components to intervention delivery as patients with HF during adulthood (acquired not congenital)
previously outlined for interventions to improve exercise and only such patients, whether interventions tested are
adherence.26 Physical therapists should consider interventions utilized by physical therapists, whether
strategies for improving adherence when implementing the reviews were of randomized controlled studies, and

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key action statements contained in the present CPG. whether outcomes tested were relevant for physical
therapy. Due to the extensive amount of systematic
In summary, given the high incidence of HF readmissions reviews, most of which had substantial overlap of included
within the first 30 days following hospital discharge, randomized controlled trials (RCTs), the GDG decided to
physical therapists can play an important role in routinely only review individual RCTs if significant gaps in
assessing for signs and symptoms of decompensation and systematic review coverage were noted. Based on these
offer patients appropriate advice based on their criteria, 127 systematic reviews, meta-analyses or CPGs
symptomology. The results of their assessment should be were determined to be relevant for the development of the
communicated with the rest of the health care team. The present CPG. A flow chart of article selection is provided in
early detection of HF exacerbation by the physical Appendix 2.
therapist with prompt medical follow-up can prevent further
clinical deterioration and subsequent hospital Clinical practice guidelines published from 2008 to 2014
readmissions, and is also required for safe and appropriate were searched including the same key words and MeSH
implementation of the key action statements in the present terms using the National Guideline Clearinghouse (NGC,
CPG. www.guideline.gov/) database. The NGC database
identified 277 guidelines using the key word of “heart
failure,” of which 16 were deemed as appropriate to be
Methods reviewed by the GDG.
The GDG was comprised of physical therapy educators with
extensive clinical and research experience in cardiovascular
and pulmonary practice. The GDG referred to previous work Evidence Summary Tables
from the CVP section as well as other APTA-supported CPGs Evidence summary tables with data extracted from the
and international CPG-development processes. In July 2014, included articles (demographics of subjects, total number
the GDG initiated the process of subjects, total number of RCTs, inclusion/exclusion
to develop a list of topic areas to be covered by the CPG criteria, intervention parameters, measures of effect size,
after polling the CVP section. Topic areas were brought key conclusions and observations, overlap of RCTs
forward by CVP section members that were included by between systematic reviews/meta-analyses, etc) for each
the GDG as considerations that molded our decision intervention were developed by 3 members of the GDG
making of inclusion or exclusion. A list was developed to and then each was reviewed by 2 other members for
determine the focus of the CPG by input by CVP accuracy. These tables were reviewed by all members of
members and the GDG formulated the scope of the CPG. the GDG prior to meeting for key action statement
development and were the basis for the development of
each key action statement.
Literature Review
A search strategy was developed and performed under
advisement of 2 librarians and by the GDG members to Appraisal of Evidence
identify literature published prior to January 2018 The appraisal team consisted of CVP section members who
addressing HF. Searches were performed in the following were interested in HF and represent both clinicians and
databases: PubMed, CINAHL, and Cochrane Database of educators. One of the GDG investigators oversaw the
Systematic Reviews. MeSH headings were used when appraisal team and sent the articles to the appraisers using a
possible for key words. Results were limited to articles random approach. Prior to sending the appraisal team articles
written in English. The search strategy by key words, that were included in this CPG for review, the reliability of the
MeSH terms, and databases is shown in Appendix 1. appraisers was established. Each appraiser was paired with
Using this search strategy, 32,862 non-duplicate another appraiser and asked to appraise an article individually.
publications were identified. To narrow this search, the After the article was appraised
focus was placed on meta-analyses, systematic reviews, by each appraiser, the pair of appraisers then compared
and clinical practice guidelines, which resulted in 356 their appraisals of the article. The pair of appraisers had

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Heart Failure Clinical Practice Guideline

Table 3.
Grades of Recommendation for Action Statements

Grade Recommendation Quality


A Strong A preponderance of level I studies
B Moderate A preponderance of level II studies
C Weak Single level II study or a preponderance of level III and IV studies, including consensus statements
D Theory A preponderance of evidence from animal or cadaver studies, from conceptual/theoretical
models/principles, or from basic science/bench research, or published expert opinion.
P Best practice Recommended practice based on current clinical practice norms.
R Research An absence of research on the topic, or conclusions from higher-quality studies on the topic are

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in disagreement.

to be within 1 point on the appraisal tool. If there was Role of the Funding Source

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disagreement greater than 1 point, the pair of appraisers The Cardiovascular & Pulmonary Section of APTA and
discussed their reasoning to determine why the score was APTA provided funds to support the development and
different. Discrepancies that were not able to be resolved preparation of this document but had no influence on the
were graded using the mean of the 2 appraiser scores. content or the key action statements of this clinical
practice guideline. The guideline is editorially independent
The use of specific appraisal tools was decided upon by from the funding source.
the GDG after attending the APTA Guideline Education
session. The Appraisal of Guidelines, Research and
Evaluation, or AGREE II was utilized for CPG critical
Document Structure and
appraisal. The Assessment of Multiple Systematic Scope of the CPG
Review (AMSTAR) tool was used for appraisal of The key action statements are organized in Table 4 with
systematic reviews. The University of Oxford Centre for their assigned recommendation grade, followed by a
Evidence-Based Medicine critical appraisal tool was used standardized content outline that was generated by
for randomized controlled trials.27 BRIDGE-Wiz software (http://gem.med.yale.edu/BRIDGE-
Wiz/). The key action statements are organized with a
The GDG decided on using the level of evidence content title that addresses the specifics of the statement,
classification that was utilized by previously published a recommendation of an observable action, the evidence
physical therapy CPGs (Tab. 3). Table 3 shows the criteria quality for the key action statement, and strength of the
for the grades/strength of recommendation for the key recommendation. Each action statement describes the: (1)
action statements. The grade represents the strength of benefits, harms, and potential costs associated with the
recommendation that reflects the quality of evidence that recommendation, (2) delineation of the assumptions or
the GDG feels supports a given key action statement. judgments in formatting the recommendation, (3) potential
reasons for intentional vagueness within the
recommendation, (4) role of patient preferences, and (5)
exclusions. Each key action statement is then followed by
External Review Process by Stakeholders a summary of evidence to highlight the interpretation of
Fourteen of 18 stakeholders responded to the call for evidence, justify the strength of recommendation, and
review. Four reviewers declined the invitation to review and assist clinicians with implementation of the key action
provide feedback. The reviewers constituted stakeholders statement. The GDG regularly met for extensive discussion
from inside and outside of the physical therapy profession: based on data extracted in the evidence summary tables to
members of the Cardiovascular and Pulmonary Section, reach consensus regarding each key action statement.
previous CPG authors, present or past journal editorial Much of the variability in considering the strength of
directors, a health care provider who also has HF (patient evidence for a guideline was eliminated for the GDG with
representative), and selected members of the American the inclusion of only systematic reviews and meta-analyses
Association of Cardiovascular and Pulmonary of RCTs. When discussions about evidence did occur, they
Rehabilitation and American College of Sports Medicine were based on easily identified criteria within the evidence
were provided with the opportunity to review and give summary tables, such as the number of subjects, number
feedback on the written document. All stakeholder of trials, study criteria, and patient characteristic, and were
comments were reviewed by the GDG and changes were therefore easily resolved. In deliberating the strength of the
made where the GDG felt the feedback was warranted. recommendation, the GDG utilized the Clinical Practice
Guidelines We Can

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Heart Failure Clinical Practice Guideline

Table 4.
Key Action Statementsa

Number Statement Key Phrase


1 Physical therapists and other health care practitioners should advocate for increased total daily Advocate for increased total daily
physical activity as an essential component of care in patients with stable heart failure. (Evidence physical activity as an essential
Quality I; Recommendation Strength: A—Strong) component of care
2 Physical therapists must educate on and facilitate components of chronic disease management Educate on and facilitate chronic
behaviors to reduce the risk of hospital readmission. These measures include education on daily disease management behaviors
weight assessment, signs and symptoms of an exacerbation, nutrition, and medication
management/medication reconciliation. (Evidence Quality I; Recommendation Strength:
A—Strong)

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3 Physical therapists must prescribe aerobic exercise training for patients with stable, NYHA Class II-III Prescribe aerobic exercise training
HFrEF using the following parameters: Time: 20–60 min; Intensity: 50%–90% of peak VO 2 or peak
work; Frequency: 3–5/wk; Duration: at least 8–12 wks; Mode: treadmill or cycle ergometer or
dancing (Evidence Quality I; Recommendation Strength: A—Strong)
4 Physical therapists should prescribe high-intensity interval exercise training in selected patients for Prescribe high intensity interval
patients with stable, NYHA Class II-III HFrEF using the following parameters: Time: >35 min; training
Intensity: >90%–95% of peak VO2 or peak work; Frequency: 2–3/wk; Duration: at least 8–12 wks;
Mode: treadmill or cycle ergometer. HIIT total weekly exercise doses should be at least 460 kcal,
114 mins, or 5.4 MET-hrs. (Evidence Quality I; Recommendation Strength: A—Strong)
5 Physical therapists should prescribe resistance training exercise for upper and lower body major Prescribe upper and lower body
muscle groups for patients with stable, NYHA Class II-III HFrEF using the following parameters: 2–3 resistance training
sets per muscle group, 60%–80% 1RM, 45–60 mins per session, 3 times per week for at least 8–12
wks (Evidence Quality I; Recommendation Strength: A- Strong)
6 Physical therapists may prescribe combined resistance and aerobic training for patients with stable, Prescribe combined aerobic exercise
NYHA Class II-III HFrEF using the following parameters: Combine 20–30 minutes of aerobic training and resistance training
with 20–30 mins of resistive training, 2–3 sets per major muscle group, 60%–80% 1RM, 3 times
per week for at least 8–12 wks. (Evidence Quality II; Recommendation Strength: B- Moderate)
7 Physical therapists should prescribe inspiratory muscle training with a threshold∗ (or similar) Prescribe inspiratory muscle training
devices (ie, device where resistance is not flow-dependent) for outpatients in the home and clinic
setting with stable, Class II and III HFrEF with or without baseline inspiratory muscle weakness using
the following parameters: 30 min/day at >30% maximal inspiratory pressure (PIMax or MIP),
5–7 days/wk, for at least 8–12 wks. (Evidence Quality I; Recommendation Strength: A—Strong)
8 Physical therapists may prescribe combined inspiratory muscle training and aerobic exercise Prescribe combined inspiratory muscle
training with a threshold (or similar) device (ie, device where resistance is not flow-dependent) for training and aerobic exercise training
outpatients in the home and clinic setting with stable, Class II and III HFrEF with or without
baseline inspiratory muscle weakness using the following parameters: 30 min/day at >30%
maximal inspiratory pressure (PIMax or MIP), 5–7 days/wk, for at least 8–12 wks. (Evidence Quality:
II, Recommendation Strength: B –Moderate)
9 Physical therapists should prescribe NMES in patients with stable, NYHA Class II-III HFrEF using the Prescribe neuromuscular electrical
following parameters: biphasic symmetrical pulses at 15 to 50 hertz, on/off time 2/5 seconds, pulse stimulation
width for larger muscles of the lower extremity should be 200 to 700 us and for small lower
extremity muscles 0.5 to 0.7 ms, 20%–30% of MVIC, intensity to muscle contraction,
5–7 days/week for at least 5–10 wks to the quadriceps, gluteals, hamstrings, and gastrocnemius
(Evidence Quality I; Recommendation Strength: A—Strong)
aHFrEF = heart failure with reduced ejection fraction; HIIT = high intensity, interval training; MET = metabolic equivalent; MIP/PImax = maximal inspiratory pressure;
NMES = neuromuscular electrical stimulation; NYHA = New York Heart Association; VO2 = oxygen uptake; 1RM = 1 repetition maximum.

Trust developed by the IOM Committee on Standards for “must” and “may.”29 The use of these action words was
Developing Trustworthy Clinical Practice Guidelines.28 The deliberated by the GDG and is discussed under each key
reader will note the use of the word “should,” “may,” and action statement under the Value Judgements and
“must” as action words in each of the key action Summary of the Evidence subheadings.
statements. Lomotan et al (2010) suggest that “must”
conveys the strongest level of obligation and that guideline This CPG uses literature available prior to January 2018 to
developers rarely use the term, except in cases of a clear create the key action statements. The CPG addresses HF
legal standard or potential for imminent patient harm.29 via 9 action statements. Algorithms were created to make
“Should” is the most common deontic verb, and it conveys this CPG clinically useful and are based on the key action
an intermediate level of obligation between statements and other CPGs (see Figs. 1 and 2).

22 Physical Therapy Volume 100 Number 1 2020


Heart Failure Clinical Practice Guideline

Action Statement 1: Advocate for central and peripheral alterations and therefore serves as
increased total daily physical activity a useful therapy for patients with HF.
as an essential component of care For the purposes of this paper, we utilize operational
Physical therapists and other health care practitioners definitions for physical activity and exercise provided by
should advocate for a culture of physical activity as an
Thompson and colleagues. Physical activity is defined as
essential component of care in patients with stable heart
any bodily movement produced by skeletal muscles that
failure. (Evidence Quality I; Recommendation Strength: A
results in energy expenditure beyond resting
—Strong).
expenditure.37 Exercise as described by Thompson, is a
subset of physical activity involving structured, repetitive,
Action Statement Profile and purposeful movements in an effort to improve overall
Aggregate evidence quality. Level I. physical fitness.38

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Risks, harm, cost. Injuries from participation in activity In the past, exercise was restricted in patients with HF until
or falls. the late 1970s and 1980s. In 1988, Sullivan and colleagues
took a bold step forward and published a landmark study
on changes in exercise capacity with unmonitored exercise
Benefit–harm assessment. Preponderance of benefit.
training in ambulatory patients with HF using invasive
hemodynamic monitoring, radionuclide angiography and
Value judgments. Across the continuum of care, the lactate analysis.39 The researchers recognized
evidence supports the benefits of physical activity and improvements in exercise capacity in 12 patients with left
several associated risks associated with bed rest and ventricular HF (LVEF 24 ± 10%) following exercise training
inactivity. largely through training-induced changes in peripheral
function.40 This study was the impetus to subsequent
Intentional vagueness. None research trials that have consistently demonstrated overall
improvements in exercise capacity and quality of life in
Role of patient preferences. Evidence indicates several patients with stable HF.41 Despite extensive literature
peripheral muscle disturbances in addition to central delineating positive effects of exercise, prescriptive
cardiovascular pathology in patients with stable HF. exercise training often has several challenges to
Therefore, patients should be encouraged to increase implement. These include poor adherence, reduced
activity as much as possible to offset the adverse sequelae access to care, and limited translation of improved
exercise capacity into increased total daily physical activity.
noted with inactivity.
In these situations, encouraging physical activity through
participation in activities that individuals enjoy, in addition
Exclusions. Patients with decompensated HF. to the aforementioned psychosocial intervention strategies
for improving adherence to exercise-based interventions,
Summary of Evidence may be necessary for overcoming these challenges.
The vision statement of the American Physical Therapy
Association defines the need for therapists to transform
society by optimizing movement to improve the human Guidelines for physical activity have been disseminated
experience. In patients with HF, low levels of physical through the American College of Sports Medicine’s
activity are associated with poor prognosis, greater Exercise is Medicine (EIM) campaign, the American Heart
mortality, and lower 11-month event-free survival.30–33 Association (AHA), and the U.S. Department of Health and
Decades of research have demonstrated numerous Human Services. In general, for patients with
physiologic, musculoskeletal, and psychosocial benefits of cardiovascular diseases, these groups recommend
physical activity, both total daily energy expenditure and 150 minutes per week of moderate-intensity physical
exercise-related energy expenditure.34 These benefits may activity (eg, brisk walking) or 75 minutes per week of
translate into improved exercise capacity, quality of life, vigorous-intensity physical activity (eg, running or
and prognosis in patients with HF. jogging), or an equivalent combination.42 Physical
therapists and other health care practitioners can
A hallmark characteristic of HF is reduced exercise advocate for a culture of physical activity by
capacity. The severity of exercise limitation in patients with disseminating this dosage of physical activity to
HF is not correlated to the extent of cardiac dysfunction patients and caregivers.
alone. Several peripheral disturbances in patients with HF
have been documented, including impaired vasoreactivity, In summary, participation in physical activity, both exercise
reduced skeletal muscle oxidative capacity, functional iron and total daily physical activity, should be encouraged in
deficiency, and decreased bone mineral density.35,36 patients with HF across the continuum of care. As
Physical activity addresses both movement experts, physical therapists have a vital

2020 Volume 100 Number 1 Physical Therapy 23


Heart Failure Clinical Practice Guideline

role in recommending activity and exercise to improve Role of patient preferences. The role of shared decision
exercise capacity, quality of life and potentially improving making is essential to understanding the patient’s
prognosis and event-free survival. priorities and maximize the utilization of the education
provided.
Action Statement 2: Educate on and
facilitate components of chronic Exclusions. None.

disease management behaviors


Physical therapists must make appropriate nutrition Summary of Evidence
referrals, perform medication reconciliation, and provide The need for effective education on preventive self-care
appropriate education on preventative self-care behaviors measures is increasingly important given escalating
to reduce the risk of hospital readmissions. These hospital admissions and readmissions and high mortality in

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behaviors include: patients with HF. The complexity of HF requires patients to
recognize signs and symptoms of decompensation, have
• Daily weight measurement to identify increases greater than 2 an established action plan, comply with medications, and
to 3 lbs in 24 hours or 5 lbs over 3 days adhere to diet and exercise recommendations. The array
• Recognition of signs and symptoms of an exacerbation of self-care tasks pose challenges for patients, especially
• Action planning using the Red-Green-Yellow CHF Tool the elderly, and therefore needs to be reiterated by several
• Following a nutrition plan members of the team, including physical therapists.
• Medication management/medication reconciliation

(Evidence Quality I; Recommendation Strength: Readmission rates have been reported to be as high as 20%
A—Strong) within 30 days and up to 50% by 6 months for patients with a
diagnosis of HF.46 Reports from a cross-sectional chart-review
Action Statement Profile investigation on 435 patients admitted to an urban university
hospital with complaints of shortness of breath or fatigue and
Aggregate evidence quality. Level I. evidence of HF indicated non-compliance with medications
and diet as the most common identifiable abnormalities
Benefits: associated with clinical deterioration
• Significant reduction in all-cause hospital readmissions prior to admission.47 Education on self-management of HF
(RR = 0.59, CI = 0.44–0.80 P < .00143; 45 RR = 0.73, CI = has been found to not only decrease hospital readmission
44
0.57–0.93 ; RR = 0.87, CI = 0.79–0.95 ) for patients with heart failure, but also all-cause
• Significant reduction in heart failure
43
readmissions (RR = readmissions and possibly decreased mortality in this
0.44, CI = 0.27–0.71, P < .001 ; RR = 0.70, CI =
0.61–0.8145; RR = 0.66, CI = 0.52–0.8344) population.43,48–50 However, there are important caveats to
this body of evidence, including definition of and lack of
consistency in patient education interventions, variability in
Risks, harm, cost. None. the delivery of interventions (in isolation vs. as part of a
specialized team approach) and the effect on mortality.44,51
Benefit–harm assessment. Preponderance of benefit. Furthermore, it appears that patient education
on self-monitoring alone (and not other chronic disease
Value judgments. The GDG utilized “must” in the key self-management techniques) for acute decompensation
action statement based on the overwhelming is ineffective for reducing hospitalization compared with
preponderance of evidence indicating the benefits of implantable wireless pulmonary artery pressure
patient education on reducing hospital readmissions. monitors.52
The extent to which a physical therapist performs
components of medication reconciliation is expected to Several systematic reviews have focused exclusively
depend on practice setting and level of clinical on self-care strategies and disease management programs
experience. and have documented positive outcomes in patients with HF.
Jovicic et al43 completed a systematic review of
6 randomized controlled trials involving self-management
Intentional vagueness. Although existing research has interventions for 857 patients, 18 years of
not studied use of chronic disease self-management
age or older and diagnosed with HF. The authors reported
interventions in patients with HF when performed that self-management significantly decreased all-cause
exclusively by physical therapists, the GDG believed that hospital readmissions by 41% (RR = 0.59, CI = 0.44–0.80;
such interventions were appropriate to be performed by P < .001), decreased HF readmissions by 66% (RR =
physical therapists, especially in the context of the 0.44, CI = 0.27–0.71; P < .001) with no change in HF-
interprofessional team. related mortality with cost savings of $1300–$7515 per
patient per year.43

24 Physical Therapy Volume 100 Number 1 2020


Heart Failure Clinical Practice Guideline

Holland published a systematic review of 30 randomized is high in fresh vegetables, fruits, low-fat dairy products,
controlled trials involving patients 56 to 86 years of age and whole grains, poultry, fish, and nuts and is low in sweets,
NYHA Classification II to IV.53 Common elements within the sugar-sweetened beverages, and red meats. Further,
education included one-to-one education concerning HF, this diet reduces consumption of saturated fat, total fat, and
medications, diet, exercise advice, symptom monitoring, and cholesterol while increasing dietary potassium,
self-management across a number of visits. Patients also magnesium, calcium, protein, and fiber. Adopting a dietary
received phone calls at a rate of 1.4 calls per month on plan based on DASH guidelines has been shown to reduce
average and had access to remote monitoring. The results systolic BP readings by 8 to 14 mmHg.56 Dietary guidelines
indicate a reduction in all-cause hospital readmissions by with an adherence to sodium restrictions is also useful in
13% (RR = 0.87, CI = 0.79–0.95), and reduced all-cause preventing HF exacerbations. A Cochrane Database
mortality by 20% (RR = systematic review in 2013 indicates a 2- to 8-mmHg drop in
0.79, CI = 0.69–0.92). Additionally, HF admission systolic BP with the utilization of this dietary sodium

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decreased by 30% (RR = 0.70, CI = 0.61–0.81). 45 restriction of no more than 100 meq/day.57 In light of the
known association between sodium intake and
McAlister et al provide the results of 29 randomized hypertension, LV hypertrophy, and cardiovascular disease,
controlled trials involving 5039 patients that primarily the AHA recommends restriction of sodium to 1.5 g/d to be
focused on the outcomes with the use of a multidisciplinary appropriate for most patients with Stage A and B HF.11 For
team approach in the management of patients with HF.54 patients with Stage C and D HF, the AHA recommends
The investigators divided the trials into 2 homogeneous sodium restriction to less than 3 g/day.11 The authors noted
groups of studies. The multidisciplinary team approach that there was insufficient evidence to support a more
demonstrated reduced all-cause mortality by 25% (RR = significant sodium restriction for those with stage C and D
0.75, CI = 0.59–0.96), HF hospitalizations by 26% (RR = HF. Therefore, physical therapists should inquire with the
0.74, CI = 0.63–0.87), and all-cause hospitalizations by interdisciplinary team as to any specific dietary recom-
19% (RR = 0.81, CI = 0.71–0.92). Trials that involved mendations provided to the patient and regularly inquire
programs for enhancing self-care activities reduced HF about and encourage the patient to be adherent with those
hospitalizations by 44% (RR = 0.66, CI = 0.52–0.83), and recommendations.
all-cause hospitalizations by 27% (RR =
0.73, CI = 0.57–0.93) with no effect on mortality (RR = In regards to medication management, the APTA position
1.14, CI = 0.67–1.29).55 Further, in 5 out of 6 trials that statement adopted by the House of Delegates advocates
assessed compliance, higher adherence rates to that physical therapists assist patients in medication
medications occurred in those treated with the management in an effort to promote patient safety and
multidisciplinary team approach, and 15 out of 18 studies reduce hospital readmissions. Further, medication
evaluated cost observed improvements in cost savings. reconciliation is the third goal of the 2011 National Patient
None of the studies included in this systematic review Safety Goals delineated by the Joint Commission on
specifically involved physical therapy services. Accreditation for Health Care Organizations. The goal
discusses improving the safety of using medications and
Education on self-care strategies involves calls on organizations to accurately and completely
teaching the patient a variety of behaviors, including daily reconcile medications across the continuum of care.
weight assessment, recognition of signs and symptoms of
exacerbation, nutrition, and medication management. In In clinical practice, patients often receive new medications
2009, Boren provided a systematic review of 35 or have changes made to their existing medications at
randomized controlled trials involving 7413 patients with various times in transitions of care. These changes place
HF.48 The investigators identified 20 different educational patients at risk for adverse drug events if all medications
topics (average of 6.6 topics covered per study), are not routinely reconciled at various points during
which were categorized into 4 major categories, including the continuum of care from acute care to rehabilitation and
knowledge and disease management, social interaction and home care. Medication reconciliation is a process of
support, fluid management, and diet and activity. 48 Physical comprehensively reviewing all medications that the patient
therapists can address these during their examination and is taking, in an effort to create the most accurate list of
intervention with patients to optimize patient outcomes. medications that can be compared against the physician’s
admission, transfer, and/or discharge orders, with the goal
The importance of nutrition in mitigating the progression of providing correct medications and maximizing patient
of HF has been repeatedly emphasized in several safety. When conducting a medication reconciliation
CPGs published by the American College of Cardiology intervention, the therapist must consider identifying
and European Society of Cardiology.11,56 The utilization of all the medications that the patient is in fact taking,
the Dietary Approaches to Stop Hypertension (DASH) comparing that to what the physician prescribed, checking
Diet is highly recommended as a useful dietary approach for interactions, duplications, and omissions, contacting the
for individuals with HF and hypertension, both of which physician to collaborate as needed, and educating the
commonly coexist in patients. The DASH diet patient regarding the same. The rehabilitation professional

2020 Volume 100 Number 1 Physical Therapy 25


Heart Failure Clinical Practice Guideline

can have a role in this process, and is currently Value judgments. The guideline developers have utilized
a required standard of practice in home health settings. “must” in the key action statement based on the
overwhelming preponderance of evidence, but clinicians
Several systematic reviews and CPGs support the use of should recognize that “must” is applicable only for patients
educational interventions in HF. Although physical who are consistent with the populations studied.
therapist services have not been explicitly included in
prior research, physical therapists, as members of the Intentional vagueness. Only aerobic exercise training
interprofessional team, must include education on self- parameter ranges are provided in the present guideline as
care behaviors as part of the overall care in an effort to there has been a lack of standard parameters used across
reduce hospitalizations and maximize outcomes in studies. Setting of exercise training is not specified though
patients with HF. home-based training programs are significantly less
studied. The only modes of exercise that have been

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extensively studied have been cycle ergometry, treadmill
Action Statement 3: Prescribe walking, or dancing. However, other modes of aerobic
aerobic exercise training training would be appropriate, especially when adapting
Physical therapists must prescribe aerobic exercise the exercise prescription to individual patient preferences.
training for patients with stable, NYHA Class II to III HF
using the following parameters: Role of patient preferences. Given that intervention
durations in included studies frequently exceeded
Time: 20 to 60 minutes.
3 months, and that continued adherence is required to
Intensity: 50% to 90% of peak VO2 or peak work. maintain training effects, selection of training parameters
should consider self-efficacy, readiness for behavior
Frequency: 3 to 5 times per week.
change, patient preferences, and individual constraints.
Duration: at least 8 to 12 weeks.
Exclusions. The use of aerobic exercise training has not
Mode: treadmill or cycle ergometer or dancing.
been studied in patients who are unstable/acutely
(Evidence Quality I; Recommendation Strength: decompensated, who have significant musculoskeletal or
A—Strong) pulmonary comorbidities, or who are in an inpatient
setting or who have significant comorbidity. Therefore,
clinical judgment must be used in the decision to include
Action Statement Profile
aerobic exercise training in these populations.
Aggregate evidence quality. Level I.
Summary of Evidence

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Benefits:
Of all rehabilitation interventions for individuals with HF,

Improved peak VO2 (weighted mean difference [WMD] aerobic exercise training is by far the most studied. The
1.04–4.9 mL/kg/min) proportional to training intensity recommendations in the present key action statement are
where higher training intensities yield greater changes
based on 26 meta-analyses of over 50 randomized trials of
in peak VO241,58–78
• exercise training that include aerobic exercise
Improved QoL (WMD 5.83–9.7 points on the Minnesota
Living with Heart Failure Questionnaire training.41,58–79,81–83 The strength of language used in the
[MLHFQ])41,62,63,73,77–79 present key action statement (ie, “the clinician must”)

Reduced all-cause and HF-related hospital reflects this overwhelming preponderance of evidence
admissions and hospital days (RR = 0.61–0.64 and and makes clear that in appropriately selected individuals,
0.92, respectively)63,66,73,78
aerobic exercise training confers clear benefits across a
variety of important health-related outcomes.
Aggregate evidence quality. Level II.
The characteristics of individuals studied and upon whom the
Benefits: present guideline is based are relatively narrow. Although a

Potential improvement in LVEF (2%–3%), EDV, significantly greater proportion of subjects studied were men,
ESV41,60,64,75 younger in age (ie, late 50s to early 60s), NYHA Class II to III,

Potential improvement in survival63,80
and had HFrEF, those who are older, female, and/or have
HFpEF may still benefit,62,63,67,84 though the effects may be
Risk, harm, cost. No additional adverse events beyond attenuated.63 In an analysis of trials that included individuals
usual care. 70 to 81 years old,67 significant improvements compared to
the control were noted for 6MWT and generic HRQL, but not
Benefit-harm assessment. Preponderance of benefit. for hospitalization, mortality, or peak VO2. Those with NYHA
Class IV are substantially under-represented, but may still
benefit with an attenuated effect.63 However, patients with

26 Physical Therapy Volume 100 Number 1 2020


Heart Failure Clinical Practice Guideline

Class IV HF who meet the criteria for clinical stability may for this potentially important variable with regard to
not be found in routine clinical practice. Specifically with specificity of training and whether walking-based training
regard to HFpEF, 4 separate meta-analyses with significant modes result in better functional or HRQL outcomes given
overlap of the same 8 studies concluded that the benefits that walking is a component of many functional activities.
of exercise training were similar to that of those with
HFrEF, though only 5 of the 8 studies included aerobic With regard to combined aerobic and resistance exercise
exercise training alone (the others included NMES, IMT, or training, the research that directly examines the addition
combined aerobic and resistance training).67,81–83 One study of resistance/strength training is limited, and does not
identified an improved E/e’ ratio (a measure of atrial appear to offer additional benefit to peak VO2. This is
pressure associated with diastolic dysfunction) following discussed in greater detail in the combined aerobic and
aerobic training as a possible mechanism for the resistance exercise training key action statement.
improvements in exercise tolerance and cardiac function.85

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No study reported any adverse events, regardless of the The setting of exercise training is not specified in the
exercise training mode. present key action statement, though home-based training
programs are somewhat less studied compared with
With regard to comorbidities, clinical trials of aerobic outpatient, clinic-based settings. However, the 2010 and
exercise training largely exclude individuals with 2016 reviews by Dalal et al92 and Zwisler et al,68
musculoskeletal or pulmonary diseases that affect the respectively, found no difference in exercise capacity and
individual’s ability to exercise, so generalization of the HRQL outcomes based on setting. In comparing home-
present key action statement to those with significant based aerobic exercise to usual activity, Chin et al47 found
comorbidity is limited. A sub-group analysis from the HF- significant improvements in peak VO2 and 6MWT of a
ACTION trial found that in patients with cancer and HF, magnitude comparable to those reported in other
there was no benefit in peak VO2 or HRQL outcomes analyses, but found no difference in HRQL.
compared to the usual care group, and there was an
increased risk of cardiovascular mortality and With regard to patient safety, a meta-analysis by Smart et
hospitalization in the exercise training group among those al61 noted that there were no deaths in 60,000 patient
who were not able to adhere to the training protocol.86 exercise hours and that there was a lower adverse event
rate in exercising subjects compared to control. Similarly,
Although a wide range of training parameters were studied, Ismail et al found no reported deaths in 123,479 patient
and all but 269,76 subgroup analyses failed to identify a exercise hours.59 In addition, the HF-ACTION trial, which
substantial effect of training parameters on measured included 1159 subjects completing 36 exercise sessions
outcomes,62–65,78,87 there appears to be a benefit to (total of 41,724 patient sessions), found no difference in
providing aerobic exercise training using a relatively higher the number of subjects having an adverse event within
intensity, interval-based format compared to similar training 3 hours of an exercise training session, and there was no
volumes using a lower intensity, continuous training difference in all-cause death or hospitalization in the
format.58,64,76,88,89 It should be noted that the use of high- 30-month follow-up period.93 Finally, a recent randomized
intensity interval training (ie, > 90%–95% of peak work or trial in patients with hypertrophic cardiomyopathy
peak VO2 is covered in a separate key action statement in demonstrated that moderate intensity aerobic exercise
the present guideline), where outcomes associated with improved aerobic capacity without any difference in
this method of high-intensity interval training are superior adverse events.94 As to whether cardiopulmonary exercise
to those found in interval and continuous training testing (CPET) is required prior to initiating an aerobic
intensities of <90% of peak work/peak VO2.63,69,75–77,90 exercise training program for ensuring safety and
However, when confining the discussion about training determining exercise training intensity, no patients were
parameters to continuous aerobic exercise training at reported as having withdrawn due to safety issues during
training intensities less than 80%, Vromen et al69 found that CPET when they met the inclusion and exclusion criteria.
total energy expenditure during the program was the most This suggests that CPET is not needed with proper patient
selection according to the criteria identified in the present
important determinant of improvement in peak VO2. key action statement. Clinical judgment, in consultation
with other pre-exercise screening guidelines, is needed for
The modes of aerobic exercise training that have been those patients not well-studied.95 Without a baseline CPET,
studied include treadmills, cycle ergometers, dancing, and exercise intensity would need to be guided by use of
aquatic exercise. With regard to dancing, a meta-analysis predicted maximum HR (in those not using beta blockers)
of 2 trials (total of 181 subjects) by Gomes-Neto and RPE, recognizing the potential issues of under-dosing
et al demonstrated improvements in peak VO2 and HRQL exercise with RPE.93 Therefore, practical application of the
compared to controls but not aerobic exercise.74 With regard to present key action statement to patients typically seen in
aquatic exercise, 4 of 5 low-quality studies reviewed by Graetz clinical practice across the continuum of care should
et al found small improvements in peak VO2.91 Unfortunately, consider clinical stability, current status of coronary artery
no meta-analysis has accounted disease, and history of and risk for arrhythmia, etc, and

2020 Volume 100 Number 1 Physical Therapy 27


Heart Failure Clinical Practice Guideline

should consider appropriate clinical measures for Value judgments. None.


measuring exercise intensity.

Given that intervention durations in included studies Intentional vagueness. There is no consensus for
frequently exceeded 3 months, and that continued adherence screening of patients for eligibility to participate in high-
is required to maintain training effect,96 strategies to enhance intensity training, including the need for baseline
adherence to exercise should be considered. In the HF- CPET.
ACTION trial,97 exercise adherence, measured by number of
minutes per exercise per week, decreased from a median of Role of patient preferences. Adherence is thought to be
95 minutes per week by the 4- to 6-month follow-up to 74
higher with shorter, higher intensity, interval-based
minutes per week at 10- to
sessions.59,76
12-month follow-up (full adherence was defined as

Downloaded from
>120 minutes per week). A subgroup analysis by Cooper
et al98 revealed that, although perceived social support was Exclusions. Patients for whom high intensity and high
not associated with clinical outcomes, it was associated heart rates might be contraindicated (eg, some
with exercise adherence. Characteristics of patients with types/settings of ICDs, history of exercise-related adverse
low adherence (<90 minutes per week) included those events, suboptimally treated coronary artery disease).
who were female, younger, black, NYHA Class III to IV,
and had lower baseline exercise capacity and HRQL.
Summary of Evidence

https://academic.oup.com/ptj/article-abstract/100/1/14/5714224 by guest on 13 April 2020


Action Statement 4: Prescribe high- The evidence surrounding the safety and efficacy of HIIT
training for patients with HF is mounting, and the
intensity interval exercise training in developers expect that future revisions to the present
selected patients guideline will include a recommendation for this mode of
Physical therapists should prescribe high-intensity, interval- exercise with the strongest (ie, “must”) language. However,
based exercise (HIIT) for patients with stable, NYHA Class there still are relatively few studies using small sample
II to III HFrEF using the following parameters: sizes, and it should be noted that there is a paucity of
evidence surrounding patient selection and predictors of
Time: >35 total minutes of 1 to 5 minutes of high intensity those who respond best to this type of training.76 As with
(>90%) alternating with 1 to 5 minutes at 40% to 70% other key action statements in the present guideline,
active rest intervals, with rest intervals shorter than the extrapolation to those patient characteristics not well-
work intervals. studied or not yet studied (eg, HFpEF, Class I and IV, older
adults, women) is challenging. Additionally, Haykowsky et
Intensity: >90 of peak VO2 or peak work.
al75 recommend that before performing HIIT, all patients
Frequency: 2 to 3 times per week. with HFrEF should undergo CPET and all training sessions
Duration: at least 8 to 12 weeks. should be performed in a supervised setting after careful
assessment and with monitoring. In contrast, Ismail et al76
Mode: treadmill or cycle ergometer. suggest that verification of tolerance to lower intensity
(Evidence Quality: II, Recommendation Strength: exercise may be sufficient to progress toward increasingly
B—Moderate) higher intensities. Therefore, the present CPG is unable to
make a specific recommendation about the need for
baseline CPET.
Action Statement Profile
Aggregate evidence quality. Level II. With regard to on/off training parameters, most studies
ranged from 1 to 5 minutes of high intensity (>90%)
Benefits: alternating with 1 to 5 minutes at 40% to 70%, with the
• Improved peak VO2 of 1.0 to 2.14 mL/kg/min above most common paradigm being 4 bouts of 4 minutes at
that achieved with moderate-to-vigorous intensity high intensity with 3 minutes of low intensity active rest
continuous exercise training.58,59,75,76,90 intervals (total > 28 minutes). The majority of studies
• Reduced mortality rate as well as all-cause and HF- used active rest intervals rather than non-active rest
related hospital admissions and hospital days, but not
better than other intensities of exercise training.59,76 intervals, and those that used non-active rest intervals
used shorter work intervals of 30 to 60 seconds.
Risk, harm, cost. Deaths and other adverse events were
not different compared to controls and other exercise Some variation existed with regard to total training time
training intensities. per session, with most between 28 to 40 minutes of total
training time. The analysis by Ismail et al76 found slightly
Benefit-harm assessment. Preponderance of benefit. better improvements in peak VO2 with sessions lasting
greater than 35 minutes and that total weekly exercise

28 Physical Therapy Volume 100 Number 1 2020


Heart Failure Clinical Practice Guideline

doses should be at least 460 kcal, 114 minutes, or 5.4 MET


• Value judgments. The GDG was unable to recommend
this key action statement at the highest level (eg, “must”)
hours to produce the greatest changes in peak VO2.76 due to issues related to limited sample size and narrow
As noted in other key action statements within the present patient selection criteria.
guideline, adherence should be a primary consideration for
intervention selection for any given patient. With regard to Intentional vagueness. Although a significantly greater
HIIT, greater adherence/reduced study withdrawal was proportion of subjects studied were middle-aged men, sex
found in those studies using interval training and session should not be used to exclude women, given that Pu et al
durations <35 minutes and were able to attain similar included only women with effect sizes equal to or better
outcomes as those protocols with longer session than those of the younger male cohorts.103
durations.76,77 Taken together, shorter HIIT sessions may
allow for the greatest long-term adherence, although this Role of patient preferences. Effect sizes on all main

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has not been verified, and Ismail et al76 suggest that outcomes in RT are similar to that of aerobic training, and
maintenance of benefit (after 3 months) might be therefore patient preference for mode of exercise to
accomplished by reducing session frequency. improve long-term adherence should factor significantly
into treatment planning.
With regard to clinical setting for the performance of HIIT, it
has only been studied in supervised, outpatient settings. Exclusions. Patients with NYHA Class IV were excluded
Thus, extrapolation of safety and efficacy to independent, from all trials. Giuliano et al100 note that, “Resistance
home-based exercise may not be appropriate. exercise has an effect on skeletal muscle, but elicits less
strain on the cardio-respiratory system compared to
aerobic exercises. It may therefore be a suitable alternative
Action Statement 5: Prescribe for patients with CHF.” However, they also note that the
resistance training absence of data does pose a problem for issuing
Physical therapists should prescribe resistance training for guidelines for the use of RT in the elderly and those with
the upper and lower body major muscle groups for patients severe disease. Inclusion of resistance training in addition
with stable, NYHA Class I to III HFrEF using the following to an aerobic exercise program is considered under a
parameters: separate key action statement.
Time: 45 to 60 minutes per session.
Summary of Evidence
Intensity: 60% to 80% 1RM, 2 to 3 sets per muscle group. The evidence utilized to create the above
Frequency: 3 times per week. recommendations were based on 5 systematic reviews on
resistance training in patients with HF.99–102,104 Each
Duration: at least 8 to 12 weeks. systematic review evaluated the impact of resistance
(Evidence Quality I; Recommendation Strength: training alone or in combination with aerobic training on the
A—Strong) outcome variables measured. These systematic reviews
utilized for this key action statement encompassed
evaluation of over 2000 patients and, in 1 systematic
Action Statement Profile review alone, over 31,263 patient hours of resistance
Aggregate evidence quality. Level I. training.99

Benefits: The patient populations examined as part of these



Improved aerobic capacity (WMD systematic reviews were Class I, II, and III HF. In the
0.52–3.99 mL/kg/min)99–102 and 6-minute walk test included studies, the participants were mostly men greater
distance (WMD 41.77–59.26 m)99–101 than 50 years of age and HFrEF. Patients with HFpEF

Improved99–101
quality of life (WMD 5.71 points on the were excluded in all studies of resistance training in HF.
MLHFQ)

Improved strength using 1 RM (but not high velocity Variables measured included HRQL, functional capacity
movement using isokinetic testing) (standardized
change score 0.43–0.77)100 such as 6-minute walk test (6MWT) and VO2 max, strength
and cardiac function. All 4 systematic reviews
acknowledge no issues with safety related to resistance
Risk, harm, cost. No documented risks or harms other training in HF.99–102
than transient musculoskeletal pain that may require
adjustment of the exercises performed. Valsalva maneuver The intensity of the resistance training interventions in
should be avoided (evidence grade V). studies included in 3 out of 4 of the systematic reviews
used a resistance training intensity of exercise set at 60%
Benefit–harm assessment. Preponderance of benefit. to 80% of the 1 repetition maximum (1RM). The one other
systematic review showed a majority of studies using 40%
to 60% of 1RM. A majority of study participants exercised

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Heart Failure Clinical Practice Guideline

2 to 3 days per week. The studies examined in the that initially the physical therapist is conservative in
systematic reviews also tended to be longer in duration, addressing the progression of strength in patients with HF.
with some studies lasting up to 6 months in duration. The
mode of exercise varied widely from study to study within Although Valsalva can occur with higher weight loads,
the separate systematic reviews. Modes included anything evidence towards the negative effect of the Valsalva is
from traditional to wrist and ankle weights to hydraulic and weak and conscious cuing on the part of the physical
pneumatic resistance. However, studies often just referred therapist to avoid the Valsalva maneuver can increase the
to progressive resistive exercise (PRE) and did not define a patient’s safety during the task. The increase in core
mode of exercise. In addition, bouts of exercise alternated stability using the Valsalva maneuver when lifting can also
between high intensity intervals and continuous bouts of 8 be accomplished, without increased atrial pressure, using
to 10 reps of a single exercise. forced exhalation during lifting.108 The clinician should also
consider repetition to failure. If a patient is easily able to

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With regard to selection of interventions, resistance training complete 10 reps of an exercise, reassessment of 1RM
provides an alternate mode of exercise with expected may be warranted.104
clinical outcomes comparable to that of other interventions
considered in the present CPG, although it should be noted With regard to safety, no systematic review reported an
that there are no meta-analyses and only a few individual increase in adverse events associated with resistance
trials of resistance versus aerobic exercise training.105–107 training. However, it is important to note that the patients
Clinical trials have only focused on the addition of studied met relatively strict inclusion criteria. Transient
resistance training to aerobic exercise, and is thus a musculoskeletal pain was the most commonly reported
separate key action statement. Resistance training can be complication among studies that was able to be resolved
especially effective in patients that do not tolerate through adjustment of the exercises performed with few
continuous or interval aerobic training or other therapeutic subsequent drop-outs.
modalities. Accommodating patient preference for mode of
exercise may increase patient adherence, and thus
resistance training should be offered as an option.
Action Statement 6: Prescribe combined
resistance and aerobic training
Physical therapists may prescribe combined aerobic and
No study included measures of functional status (other resistance training for patients with stable, NYHA Class
than HRQL measures) to offer insight as to the ways in II to III HFrEF using the following parameters:
which improved muscular strength and endurance translate Time: 20 to 30 minutes of resistance training added to
into improvements in daily function, especially in individuals aerobic exercise training.
with focal muscle weakness directly contributing to
movement dysfunction, such as gluteal or gastrocnemius- Intensity: 2 to 3 sets per major muscle group, 60% to 80%
soleus weakness contributing to abnormal gait patterns 1RM.
and/or mechanical inefficiencies with gait. It is important for Frequency: 3 times per week.
physical therapists to determine whether strength deficits
that relate to function and utilize these as a primary form of Duration: at least 8 to 12 weeks.
intervention. It is also equally important for physical (Evidence Quality: II, Recommendation Strength:
therapists to determine the patient’s 1RM at baseline to B—Moderate)
ensure that underdosing of resistance exercise does not
occur. However, testing 1RM may not be clinically feasible Action Statement Profile
in many patients, and therefore estimation of %1RM can be Aggregate evidence quality. Level II.
made using the formulas outlined in Supplementary Table
1 (available at https://academic.oup. com/ptj). In clinical
situations wherein the therapist is unable to determine 1RM Benefits (beyond those of aerobic exercise training
due to weakness, the Omni Res scale is a preferred alone):
method of increasing strength as the patient improves. • Improved muscular strength and endurance109,110
• Improved64,99
HRQL (WMD 8.3 to 10.9 points on the
Patients are asked to perform a strength-specific exercise MLHFQ)
initiated with body weight only and using the Omni Res
scale, the patient is asked to rate intensity level. This would
Risk, harm, cost. No documented risks or harms other
be the patient’s baseline Omni Res score. As an example
than transient musculoskeletal pain that may require
of patient progression, the patient is asked to perform the
adjustment of the exercises performed. Valsalva
exercise with 3 sets of 6 repetitions and rate their intensity
maneuver should be avoided (evidence grade V).
level. When the Omni Res score of intensity falls below a
level of 5, the amount of resistance increases by 1 lb. The
Omni Res scale can be used to document strength gains Benefit–harm assessment. Preponderance of benefit.
and the GDG suggests

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Heart Failure Clinical Practice Guideline

Value judgments. Because only a few studies, using benefits of exercise training were similar to that of those
small samples sizes, have empirically compared combined with HFrEF, though only 2 of the 8 studies included
resistance and aerobic training to aerobic training alone, combined aerobic and resistance exercise training (the
the developers were unable to recommend this action others included only aerobic exercise, neuromuscular
statement at a higher level. electric stimulation, or inspiratory muscle
training).67,81–83,113 No study reported any adverse events,
Intentional vagueness. Presence of baseline muscular regardless of the exercise training mode.
strength impairment.
Therefore, the amount of time a patient is willing to
Role of patient preferences. Total exercise training time dedicate to exercise training must be considered when
should be considered. determining the duration of the aerobic and resistance
training components of a combined intervention.

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Exclusions. None. Additional muscular strength and endurance benefits,
without compromise to improvement in peak VO2, were
Summary of Evidence demonstrated when resistance training was added to the
Given that: (1) the strongest recommendation level has same aerobic exercise program performed by the control
been assigned to aerobic exercise training, (2) the benefits group,114 as well as when total exercise time was held
of an added resistance training program have been constant (eg, 20 minutes of aerobic training and
relatively less well studied, and (3) the additional effects of 20 minutes of resistance training compared to 40 minutes
an added resistance training program on peak VO2 are of aerobic training only).109–111,115 Thus, the developers
limited, physical therapists should be intentional in their suggest that, when selecting a combined aerobic and
decisions to add resistance training. Although a combined resistive exercise training program, the total exercise time
exercise training program appears to result in modestly not be extended beyond what would be spent on aerobic
greater improvements in muscular strength and exercise training alone due to a risk of decreasing
endurance,109,110 adherence to a program with a greater time
commitment.116
LVEF and left ventricular end-diastolic
diameter,110 and quality of life,64,99 the added effect on peak
VO2 is much less clear.64 The addition of resistance
training is hypothesized to result in greater improvements
Action Statement 7: Prescribe
in flow-mediated vasodilation105,111 and skeletal muscle inspiratory muscle training
mass area resulting in reduced neurohumoral activation, Physical therapists should prescribe inspiratory muscle
improved LV function, and subsequent improvement in training with a threshold (or similar) device (ie, device
aerobic capacity.110,112 The 2013 meta-analysis by Smart et where resistance is not flow dependent) for patients with
al unequivocally concluded, on the basis of 4 studies, that
stable, Class II and III HFrEF with or without baseline inspi-
combined exercise training was superior to intermittent
ratory muscle weakness using the following parameters:
aerobic exercise alone for improving peak VO2.58
However, a 2016 meta-analysis by Cornelis et al64 with 1 Time: 30 min/day or less if using higher training intensity
additional study did not find any additional improvement in (>60% maximal inspiratory pressure [MIP also known as
peak VO2 with the addition of resistance training, and PIMax]).
concluded that there were errors in the 2013 Smart et al Intensity: >30% MIP.
analysis and conclusion.58
Frequency: 5 to 7 days/wk.
Although mild to moderate strength impairments were Duration: at least 8 to 12 weeks.
noted at baseline in studied subjects, no studies included
subjects with normal strength, and therefore the (Evidence Quality: I, Recommendation Strength:
developers were unable to comment on the use of A—Strong)
combined resistance and aerobic training in individuals
with minimal strength impairment. Additionally, no study
included other measures of functional status (other than Aggregate evidence quality. Level I.
quality-of-life measures) to offer insight as to the ways in
which improved muscular strength and endurance Benefits:

translate into improvements in daily function, especially in Improved maximum inspiratory pressure (MIP) (WMD
individuals with focal muscle weakness directly contributing 14.56–31.87 cmH2O)117–120

Improved sustained maximum inspiratory pressure
to movement dysfunction such as gluteal or (SMIP) (WMD 144.74 pressure time units)118

gastrocnemius-soleus weakness contributing to abnormal Improved exercise tolerance (peak VO2 WMD
gait patterns and/or mechanical inefficiencies with gait. 1.67–4.0 mL/kg/min; 6MWT WMD 23.66–80.0 m)117–120

Improved quality of life (MLHFQ WMD 12.25 points) 117

Specifically with regard to HFpEF, 4 separate meta-


analyses of the same 8 studies concluded that the

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Heart Failure Clinical Practice Guideline

Risk, harm, cost. No documented risks or harms, though dyspnea, poor quality of life, and poor prognosis.121–124 As
consideration should be given to those individuals at risk summarized below, the effects of IMT on a number of
for vocal fold dysfunction and pneumothorax, as well as important clinical outcomes has prompted some to propose
those with markedly elevated left ventricular end diastolic IMT as an alternative intervention for those who are unable
volumes. Device cost can vary. Patient time to complete an or unwilling to participate in a more traditional rehabilitation
intervention, especially with lower training intensities and program.117,125
longer durations or when combined with other
interventions, should be considered. With regard to effect of IMT alone on clinical outcomes
based on reported weighted mean differences, meaningful
Benefit–harm assessment. Preponderance of benefit.
improvements in SMIP exercise tolerance and HRQL117
have consistently been demonstrated.
Action Statement Profile

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Inspiratory muscle training at >60% MIP with It is interesting to note that these benefits have been
sets/repetitions and/or intervals to fatigue. observed across a wide range of training intensities, with
Aggregate evidence quality. Level I higher training intensities appearing to result in greater
improvements with overall less training time per session,
Benefits. Potentially greater, more rapid gains with less which might be appealing to patients unable or unwilling to
overall training time. perform IMT for 30 minutes continuously at lower
Risk, harm, cost. Potentially greater negative workloads. However, this is somewhat confounded by the
intrapleural and intrathoracic pressures than lower presence of impairment in baseline MIP. Most high
training intensities. intensity training studies except for Weiner et al126 and
Marco et al127 included patients with normal baseline
Benefit–harm assessment. Preponderance of benefit. MIP,128–130 which limits generalization to patients with
impaired baseline MIP. However, the subgroup meta-
Value judgments. Despite a Level I aggregate evidence analysis by Montemezzo et al118 found that weighted
quality, the GDG was unable to recommend this action mean differences for patients with baseline weakness
statement at the highest level (ie, “should” vs. “must”) due were greater than those without (31.87 vs. 14.72 cmH20),
to relatively small sample sizes and strict patient selection but that difference was nonsignificant.
criteria.
The synthesis of effects of IMT training intensity is also
The GDG included 2 action statements for inspiratory somewhat confounded by a lack of matching training
muscle training (IMT) (IMT alone and IMT combined with intensity to the appropriate measurement, where the effect
aerobic exercise training) because some patients may not of low intensity/high repetitions (ie, training for muscular
be able to participate in an aerobic exercise program. endurance) has mostly been assessed with tests of
muscular strength (ie, MIP). Although this issue was
Intentional vagueness. Only IMT parameter ranges are identified over 20 years ago,8 little data has since been
provided in the present guideline as there has been a lack gathered regarding the importance of inspiratory muscle
of standard parameters used across studies. The term strength versus endurance to inform decision making
“inspiratory muscle training” was used in the guideline about IMT training intensity. Although their sample size
without specifying training for endurance (low intensity/high was very small (n = 11 in the intervention group), Marco et
repetitions vs. or strength [high intensity/low repetitions]). al127 demonstrated substantial changes in both inspiratory
strength and endurance using 5 sets of 10 repetitions at
100% of the 10 RM in patients with baseline weakness.
Role of patient preferences. Amount of time the patient is So it may be that loading of any intensity induces
willing to spend on a single intervention, especially if other improvements in strength and endurance in such patients,
interventions are being utilized. but this has yet to be elucidated across multiple studies
and larger samples.
Amount of time a patient is willing to spend on 1
intervention (ie, 30 minutes of low intensity IMT) versus It is important to note that IMT has not been studied
higher intensity shorter treatment sessions. or is understudied in many individuals with HF, including
HFpEF, clinical settings other than outpatients, patients
Exclusions. None. with clinical instability, NYHA Class IV symptoms, and
significant comorbid COPD or other chronic pulmonary
Summary of Evidence disease. Palau 2014 studied HFpEF in a small sample of
In patients with HF, IMT is an intervention targeted at the patients with Class II to IV HF who had mildly impaired
underlying structural and metabolic muscle fiber changes MIP with findings similar to those already outlined.131
that contribute to impaired inspiratory muscle strength and Additionally, IMT in patients with HF and comorbid
endurance that are known to be associated with conditions might preclude the ability to demonstrate

32 Physical Therapy Volume 100 Number 1 2020


Heart Failure Clinical Practice Guideline

improvement, such as those with severe COPD with inspiratory muscle weakness as an adjunct to aerobic
hyperinflation or neuromuscular conditions that result in exercise training using the following parameters:
irreversible inspiratory muscle weakness. With regard to
Time: 30 min/day.
clinical setting, only outpatient and home-based programs
have been studied, so the evidence is unable to inform Intensity: >30% maximal inspiratory pressure (PIMax or
decisions regarding the use of IMT in other settings and MIP).
the timing of initiating IMT as a patient progresses through Frequency: 5 to 7 days/wk.
the continuum of care. Thus extrapolation to patients with
understudied characteristics and settings, although not Duration: at least 8 to 12 weeks.
inappropriate, should be performed with caution. (Evidence Quality: II, Recommendation Strength:
B–Moderate)
With regard to safety, no adverse events related IMT have

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been reported in the carefully selected patients included in Action Statement Profile
randomized trials. However, Level V evidence suggests
that IMT might be contraindicated in those at risk for vocal Aggregate evidence quality. Level II.
fold dysfunction and pneumothorax and those with Benefits (beyond those achieved with aerobic exercise
unstable asthma and emphysematous bullae near the training alone):
pleura due to the large negative airway, intrathoracic, and • Improved MIP (WMD 20.89 cmH2O)134
intrapleural pressures.132 Additional Level V evidence • Improved HRQL (WMD 4.43 points on the MLHFQ)134
raises concern for those with markedly elevated left
ventricular end diastolic volumes due to enhanced venous Risk, harm, cost. No documented risks or harms, though
return that occurs with large negative intrathoracic consideration should be given to those individuals at risk
pressures which may result in worsening HF symptoms.8 for vocal fold dysfunction and pneumothorax, as well as
For these patients, and although not well studied, those with markedly elevated left ventricular end diastolic
expiratory muscle training could be considered as this volumes. Device cost can vary. Patient time to complete an
would not be associated with large negative intrathoracic intervention especially with lower training intensities and
pressures, and improvements in expiratory muscle longer durations or when combined with other
strength may be associated with improved symptoms and interventions, should be considered.
functional performance.133
Benefit–harm assessment. Preponderance of benefit.
Finally, despite a Level I aggregate evidence quality, the
GDG was unable to recommend this action statement at Value judgments. Despite a Level I aggregate evidence
the highest level (ie, “should” vs. “must”) due to relatively quality according to the evidence grading criteria, the
small sample sizes and strict patient selection criteria. GDG was unable to recommend this action statement at
Additionally, the GDG included 2 action statements for the highest level (ie, “should” or “must”) due to relatively
IMT (IMT alone and IMT combined with aerobic exercise small sample sizes, too few studies, and strict patient
training) because some patients may not be able to par- selection criteria.
ticipate in an aerobic exercise program, and as previously
discussed, use of IMT alone in lieu of other interventions is Intentional vagueness. Only IMT parameter ranges are
one of the theoretical underpinnings of IMT. provided in the present guideline as there has been a lack
of standard parameters used across studies. The term
“inspiratory muscle training” was used in the guideline
Regarding practical application of the present CPG to
without specifying training for endurance (low intensity/high
clinical practice in patients typically seen in clinical
repetitions vs. or strength [high intensity/low repetitions]).
practice across the continuum of care, the MIP is typically
not known or measured. However, Cahalin et al provide
an excellent outline of procedures that can be used by
clinicians to measure the MIP and develop an IMT Role of patient preferences. Amount of time the patient is
prescription.133 willing to spend on combined interventions, especially if
low intensity/longer session duration IMT is added to an
aerobic exercise program.
Action Statement 8: Prescribe
Exclusions. None.
combined inspiratory muscle training
and aerobic exercise training Summary of Evidence
In patients with HF, IMT is an intervention targeted at the
Physical therapists may prescribe inspiratory muscle underlying structural and metabolic muscle fiber changes
training with a Threshold (or similar) device (ie, device that contribute to impaired inspiratory muscle strength and
where resistance is not flow dependent) for patients with endurance that is known to be associated with
stable, Class II, and III HFrEF with or without baseline

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Heart Failure Clinical Practice Guideline

dyspnea, poor quality of life, and poor prognosis. As 700 ms and for small lower extremity muscles 0.5 to
summarized in the preceding key action statement, IMT as 0.7 ms, 20–30% of MVIC, intensity to muscle
a single intervention results in meaningful improvements in contraction.
MIP, exercise tolerance, and quality of life have • Frequency: 5 to 7 days/week.
consistently been demonstrated. However, it is also • Duration: at least 5 to 10 weeks.
important to address the use of IMT combined with aerobic
exercise training. (Evidence Quality I; Recommendation Strength:
A—Strong)
Based on the 3 studies 135–137 included in the meta-analysis by
Neto et al, the addition of IMT to an aerobic exercise program
resulted in additional improvements in MIP Action Statement Profile
(12.9–23.5 cmH2O, pooled effect of 20.89 cmH2O), and Aggregate evidence quality. Level I.

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HRQL by 3.3 to 12 points on the MLHFQ (pooled effect of
4.43 points). However, there was no additional benefit in Benefits:
peak VO2 (0–1.9 mL/kg/min, non-significant pooled effect •
Improved muscle139–142
strength and endurance (WMD
of 0.89 mL/kg/min).134 25.0–30.74 Nm)

Improved VO2 max (WMD
Interpretation of these findings is confounded by 0.76–4.98 mL/kg/min)139,141,143

Improved distance in 6MWT (WMD
Winkelmann et al135 including only patients with 34.78–85.66 m)139–143

inspiratory muscle weakness and using low intensity IMT, Improved QOL (WMD 2.21–6.77 points on
compared to Adamopoulos et al136 and Laoutaris et al,137 MLHFQ)141,143
who used high intensity IMT in patients with normal
inspiratory muscle strength. For example, although the
improvement in MIP, peak VO2, and HRQL was Risks, harm, cost. There were no adverse events
significantly greater in the IMT group, Winkelmann et al135 attributable to the NMES intervention throughout the
observed substantial improvements across all measures in available evidence. Patients did experience mild self-
both groups, supporting the idea that aerobic exercise limited cramps or muscle soreness. NMES units and
alone improves ventilatory muscle function in those electrodes can vary in cost but handheld devices can be
with baseline weakness. In contrast, Adamopoulos et al136 just as powerful as larger NMES devices.
found no additional increase in peak VO2, despite
an improvement in MIP using high intensity IMT. Benefit–harm assessment. Preponderance of benefit.
Regarding feasibility for application to clinical practice, 2
of the 3 studies135,138 had drop-out rates of 21.4% and Value judgments. Despite a Level I aggregate evidence
36.8%. Only Winkelmann et al135 reported the reason for quality, the GDG was unable to recommend this action
drop-outs, which was primarily due to “logistical” reasons. statement at the highest level (ie, “should” vs. “must”) due
Given the challenges of exercise adherence in patients to relatively small sample sizes and strict patient selection
with HF, the present guideline developers believe that criteria.
selection of intervention combinations should incorporate
individual preferences to ensure adherence.21,24
Intentional vagueness. Although most studies
The reader is referred to the inspiratory muscle training key investigating NMES included a significantly greater
action statement for relevant discussion regarding IMT proportion of men, the GDG feels that the use of NMES on
safety, patient selection, and clinical application women who have similar clinical characteristics should not
considerations, which are also applicable to the present be precluded. The GDG provided a range of NMES
key action statement. parameters within this action statement because there has
been a lack of standard parameters used across studies.
Insufficient data exist regarding the use of NMES in those
Action Statement 9: Prescribe with and without baseline strength impairment.
neuromuscular electrical stimulation
Physical therapists should prescribe neuromuscular Role of patient preferences. Patient tolerance to electric
electrical stimulation (NMES) in patients with stable NYHA stimulation varies, and intensity to at least visible muscle
Class II to III HFrEF using the following parameters: contraction is required to be effective for NMES.
• Time: 30 to 60 minutes per session. Additionally, the duration of treatment investigated in the
literature is up to 2 total hours, which may affect patient
• Waveform: Biphasic symmetrical pulses at 15 to 50 Hz.
adherence due to patient discomfort.
• Intensity: On/off time 2/5 seconds, pulse width for larger
muscles of the lower extremity should be 200 to

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Heart Failure Clinical Practice Guideline

Exclusions. Patients with implanted ICDs/pacemakers are generally underrepresented in this literature. However,
were excluded from all randomized trials. However, the GDG feels that NMES may be a feasible alternative
several case series studies on patients (total of 11 patients to whole body exercise for those patients with Class
with bipolar sensing pacemakers and 6 patients with ICDs) IV HF.
demonstrated that there were not any adverse effects from
NMES.144–146 The GDG did not find literature regarding the Few studies clearly stated the instructions provided to
use of NMES in HF patients with a high risk of venous patients as to what, if any, activity should be performed
thromboembolism and/or thrombophlebitis. during NMES treatment. One study specifically instructed
patients to be ambulatory while receiving NMES. Fall risk,
baseline level of inactivity, and exercise tolerance should
Summary of Evidence be considered when providing patient instructions for
When considering options for the patient with HF, NMES patients who receive NMES during gait. The GDG

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should be considered as an option for patients with NYHA recommends that patients avoid mobility during stimulation
Class II/III HF to improve muscle weakness. Muscle to avoid the risk of falls and to perform isometric or isotonic
weakness negatively impacts functional status and quality exercises during the contraction phase for a given muscle
of life.147–149 NMES has been demonstrated to result in group.
139,141 ,143,150

substantial improvements in peak VO2 and


The literature varies regarding application of NMES and
6MWT139–143,150 compared to controls with effect sizes
similar to those found with other exercise-based specific muscle groups targeted. The GDG therefore
interventions. selected muscles that were believed to be the most
appropriate: quadriceps, hamstrings, gastrocnemius, and
NMES has also been shown to improve muscle strength gluteals. These muscles of the lower extremity were
and endurance, and improve oxidative capacity and chosen because these muscles are used for functional
capillarization of type 2 muscle fibers. Ranges of muscle activities and participation. In addition, these larger
strength improvement were noted to be between 22% muscles of the lower extremity are more tolerant to
and 35% increase in isometric and isokinetic peak increasing the intensity of the NMES. In order to deliver
torque.151,152 optimal electrical stimulation to the muscle fibers, space
should be adequate between NMES electrodes.
Consideration for appropriate sized electrodes must be
The literature includes patients with NYHA Class IV HF;
taken in order to achieve proper distribution of electrical
however, more literature is needed to support this
stimulation across all muscle fibers targeted. This will
treatment option for this class of underrepresented
increase muscular recruitment and improve patient
patients. NMES is able to serve as an evidence-based
tolerance.
option for patients with HF who may be unwilling or unable
to participate in exercise-based interventions such as
aerobic exercise, inspiratory muscle training, or resistance With regard to electric stimulation dosing, the majority of
studies used 60 minutes per session, with some using
training. Physical therapists commonly encounter patients
30 minutes, and 1 using 240 minutes. Although no prior
unwilling or unable to participate in physical therapy for studies commented on dose-response relationship, there
numerous reasons. Large variations in clinical presentation
may occur and fluctuate based on time of day impacting may be an effect of dose on peak VO 2 but not on other
activity and participation levels. This variability may result outcomes.153
in a low adherence to specific modes of exercise or limit
exercise capacity. NMES is an option for patients with HF Most studies were completed in the outpatient setting,
with noted improvements in muscle strength and with some using a home-based setting. Given that NMES
endurance in the literature. Although many patients may units are small and portable, use of NMES could be
not tolerate NMES or have barriers to obtaining the considered throughout the continuum of care.
necessary equipment, this was not a factor the GDG
believed should influence the strength of the
recommendation for NMES (ie, that NMES should be a Conclusion
lower priority than exercise-based interventions) due to the The evidence-based resources provided in this CPG
strength of existing evidence. should empower clinicians to utilize a multitude of options
to optimize patient care across the continuum of care.
Although a patient may not be able to perform all of the
Baseline weakness was not a criterion used to include or
suggestions mentioned in this guideline, this CPG intends
exclude patients. Although 1 study observed a greater
to provide the physical therapist with a toolbox of options to
percent improvement in those patients with greater
consider to maximize patient outcomes. While maintaining
baseline impairment, clinically meaningful improvements
patient safety, these options can improve functional
can be expected in those patients with NYHA Class II to
mobility within the context of the movement system and
IV HF. Although patients with NYHA Class IV HF were
optimize quality of care to those with a
included from the studies considered by the GDG, they

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Heart Failure Clinical Practice Guideline

diagnosis of stable HF. The GDG was unable to establish a


prioritization of interventions included in the present CPG
• What is the efficacy and role of exercise-based
interventions for those with NYHA Class I and
as the available research does not provide the necessary IV HF?
comparative data between interventions, nor does it
provide insight as to which is the most effective intervention
in particular subgroups of patients with HF in decreasing
readmissions, increasing function, and increasing quality of
life. Author Contributions and Acknowledgments

Concept/idea/research design: M.J. Shoemaker, K.J.


Implementation Dias, K.M. Lefebvre, J.D. Heick, S.M. Collins
Writing: M.J. Shoemaker, K.J. Dias, K.M. Lefebvre, J.D.
In order to implement and disseminate the

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Heick, S.M. Collins
recommendations of this CPG, the GDG has taken or is in Data collection: M.J. Shoemaker, K.J. Dias, K.M. Lefebvre, J.D.
the process of taking the following steps: Heick, S.M. Collins
Data analysis: M.J. Shoemaker, K.J. Dias, K.M. Lefebvre, J.D.
• Preliminary sharing of CPG recommendations at Heick, S.M. Collins
APTA’s Combined Sections Meeting 2018; Project management: M.J. Shoemaker, S.M. Collins
• Open access to the CPG; Fund procurement: J.D. Heick, S.M. Collins
• Production of podcasts about the CPG aimed at Providing institutional liaisons: K.M. Lefebvre, J.D. Heick
physical therapists;
• Presentations on the CPG by the GDG at local, state, Dr Collins and Dr Heick provided concept/idea/research design.
All authors provided writing, data collection, data analysis, and
regional, and national seminars; and
• Organization of a team in 2023 to revise the present CPG input into Key Action Statements. Dr Shoemaker, Dr Lefevbre,
Dr Dias, and Dr Heick each led the development and summary of
by 2025.
Key Action Statements. Dr Collins and Dr Shoemaker developed
the algorithms. Dr Collins and Dr Heick provided project
management, fund procurement, and consultation.
Research Needs Dr Heick managed the article review process. Dr Lefevbre
Specific research needs related to each intervention are managed the external guideline review process.
addressed within each Action Statement. Here we attempt
to provide overarching needs related to the following The authors thank the following people for their participation in the
questions: development of this guideline. Article appraisers: Jennifer Anderson,
PT, DPT, board-certified clinical specialist in cardiovascular and
• What are the variations in response or outcomes pulmonary physical therapy; Sarah Cote, PT, DPT; Abby Folger, PT,
between patients with HFrEF and HFpEF? DPT, board-certified clinical specialist in cardiovascular and pulmonary

• Of all of the exercise-related options, which are the physical therapy; Erin Haling, PT, DPT, certified safe patient handling
clinician, certified ergonomics assessment specialist I, II, III; June
most effective in particular subgroups of patients with Hanks, PT, PhD; John Imundi, PT, DPT; Kerry Lammers, PT, DPT,
HF in decreasing readmissions, increasing function and
increasing quality of life? board-certified clinical specialist in cardiovascular and pulmonary
physical therapy; Andrea Mendes, PT, DPT; Kristen Peterson, PT,
• What are appropriate interventions and exercise DPT; Julie Ronnebaum, PT, DPT, PhD, board-certified clinical
dosing/parameters for:
specialist in geriatric physical therapy; Richard Severin, PT, DPT,
◦ Patients soon after (within days) of acute board-certified clinical specialist in cardiovascular and pulmonary
exacerbation? physical therapy; Jonathan Wood, PT, DPT, board-certified clinical
◦ Patients in acute care, inpatient rehab, subacute specialist in neurologic physical therapy. External reviewers: Jason L.
rehab, or home health early post-acute care? Rengo, MSc, certified cardiac rehabilitation professional, Fellow of the
◦ Patients undergoing upward titration of cardiac American Association of Cardiovascular and Pulmonary Rehabilitation;
remodeling agents and not yet on a stable, optimal Ellen Hillegass, PT, EdD, FAPTA, board-certified clinical specialist in
pharmacologic regimen? cardiovascular and pulmonary physical therapy; Carl Fairburn, PT,
DPT; Suzanne Greenwalt, PT, DPT, board-certified clinical specialist in
• Are there variations in response or outcomes cardiovascular and pulmonary physical therapy, board-certified clinical
specialist in geriatric physical therapy; Michael Puthoff, PT, PhD;
associated with common comorbidities?
• What is the influence of combining or staging Wayne Brewer PT, MPH, PhD, board-certified clinical specialist in
orthopedic physical therapy, certified strength and conditioning
interventions (such as starting with E-Stim and specialist; Anne K. Swisher PT, PhD, FAPTA, board-certified clinical
progressing to aerobic training)?
specialist in cardiovascular and pulmonary physical therapy; Lawrence
• What is the influence of resistance training in specific Cahalin, PT, PhD, board-certified clinical specialist in cardiovascular
instances of muscle weakness (eg, targeted and pulmonary physical therapy. Grand Valley State University
therapeutic exercise)? graduate assistants:
• What particular presentations of movement dysfunction Kelly Gotberg, PT, DPT; Sarah Veldman, SPT; Kelsey
in patients with HF may warrant particular combinations
of interventions? Berry, SPT.

36 Physical Therapy Volume 100 Number 1 2020


Heart Failure Clinical Practice Guideline
Funding Heart Association Task Force on Practice Guidelines. J Am
Coll Cardiol. 2013;62:e147–239.
This work was supported by a grant from the Cardiovascular & 12 Sharma K, Kass DA. Heart failure with preserved ejection
Pulmonary Section of the American Physical Therapy fraction: mechanisms, clinical features, and therapies. Circ
Res. 2014;115:79–96.
Association (APTA) and by APTA.
13 Simonneau G, Gatzoulis MA, Adatia I, et al. Updated clinical
classification of pulmonary hypertension. J Am Coll Cardiol.
Disclosures and Presentations 2013;62:D34–41.
The authors completed the ICMJE Form for Disclosure of 14 Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA
Potential Conflicts of Interest and reported no conflicts of interest. guideline for the management of heart failure: executive
summary: a report of the American College of Cardiology
This guideline is scheduled to be updated 5 years from date of Foundation/American Heart Association Task Force on
publication. Practice Guidelines. Circulation. 2013;128:1810–1852.
15 Raphael C, Briscoe C, Davies J, et al. Limitations of the

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New York Heart Association functional classification system
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used to develop policy or suggest policy changes, or it may failure: nomenclature, classification, and risk stratification.
Am Heart J. 2003;145:S18–25.
provide discussion about current policy. However, it is up to
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the European Society of Cardiology. Developed in
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Appendix 1.
Key Words for Literature Search

Search Strategy Using PICO Format ADL training


The populations, interventions, comparisons, and Barrier accommodations or modifications
outcomes included to select evidence are included below. Device and equipment use and training
This is a comprehensive and inclusive list. Functional training programs IADL training
Injury prevention or reduction
Populations Leisure and play activities and training (relate to
Adults with heart failure sustaining an active lifestyle)
Excluding congenital causes in congruence with the Manual therapy

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ACCF/AHA 2013 guidelines (Committee et al, 2013) Massage
Including both heart failure with reduced ejection Mobilization
fraction and with preserved ejection fraction and Passive range of motion
delineate when able Prescription, application, and, as appropriate,
fabrication of devices and equipment
Interventions Adaptive devices
Coordination, communication, and documentation Assistive devices
Addressing required functions Orthotic devices
Admission and discharge planning Protective devices
Case management Supportive devices
Collaboration and coordination with agencies Airway clearance techniques
Communication & Documentation across settings Breathing strategies
Cost-effective resource utilization Manual/mechanical techniques
Data collection, analysis, and reporting Positioning
Interdisciplinary teamwork Electrotherapeutic modalities
Referrals to other professionals or resources Biofeedback
Instruction, education and training of patients/ Electrical stimulation
clients and caregivers regarding Physical agents and mechanical modalities
Current condition Compression therapies
Enhancement of performance
Health, wellness, and fitness programs Comparisons
Plan of care We included groups with all possible comparisons, such as
Risk factors for pathophysiology standard care, different interventions, and baseline com-
Transitions across settings parisons in longitudinal observational studies without a
Transitions to new roles control group.
Procedural interventions
Therapeutic exercise (particularly for Body Structures/ Outcomes
Functions: aerobic capacity/endurance, circulation, muscle Functional measures; ADLs; aerobic capacity; strength;
performance, motor function, posture, range of motion, endurance; LOS; number of visits; discharge destination;
ventilation, and respiration; Activities: self-care, quality of life; readmission rates, adverse events.
ambulation, stair climbing; Participation: home Impact on pathology/pathophysiology (Health
management, work, community leisure). Condition)
Aerobic capacity/endurance conditioning Morbidity
Balance, coordination, and agility training Disease progression
Body mechanics and postural stabilization Exacerbations
Flexibility exercises Impact on impairments (Body Structures/Functions)
Gait and locomotion training Aerobic capacity/endurance
Neuromotor developmental training Impact on functional limitations (activities)
Relaxation Ambulation, ADLs
Strength, power, and endurance training of skeletal Impact on disabilities (participation)
(including ventilatory) muscles Impact on health, wellness, and fitness (vague)
Functional training in self-care, home management, Impact on societal resources
work, community, and leisure Patient/client satisfaction

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Additional evidence selection criteria will include: Health retrospective studies, case series/case reports; and
care settings: Across the spectrum from critical care to excluded any cross sectional design studies.
outpatient (including home care). Publication status: Only published full papers were
Timeframe: No limit. included (Not unpublished manuscripts or abstracts of
Study design: We included practice guidelines, systematic conference proceedings).
reviews with or without meta-analysis; RCTs, prospective Language: Our search and inclusion included English
comparison studies, prospective non comparison studies, language publications

Appendix 2.
Flow Chart of Article Selection

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2020 Volume 100 Number 1 Physical Therapy 43

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