Efficacy of Early Respiratory Physiotherapy and

Mobilization After on-pump Cardiac Surgery: a

Prospective Randomized Controlled Trial
Georgios Afxonidis 
Panepistḗmio Thessalías - Lárisa: Panepistemio Thessalias - Larisa
Dimitrios V. Moysidis 
(

[email protected]
)
Aristotle University of Thessaloniki: Aristoteleio Panepistemio Thessalonikes
https://orcid.org/0000-
0001-9083-0267
Andreas S. Papazoglou 
Aristoteleio Panepistimio Thessalonikis: Aristoteleio Panepistemio Thessalonikes
Christos Tsagkaris 
Aristoteleio Panepistimio Thessalonikis: Aristoteleio Panepistemio Thessalonikes
Anna Loudovikou 
Aristotle University of Thessaloniki: Aristoteleio Panepistemio Thessalonikes
Georgios Tagarakis 
Aristoteleio Panepistimio Thessalonikis: Aristoteleio Panepistemio Thessalonikes
Georgios T. Karapanagiotidis 
Aristoteleio Panepistimio Thessalonikis: Aristoteleio Panepistemio Thessalonikes
Ioannis A. Alexiou 
Aristoteleio Panepistimio Thessalonikis: Aristoteleio Panepistemio Thessalonikes
Christoforos Foroulis 
Aristoteleio Panepistimio Thessalonikis: Aristoteleio Panepistemio Thessalonikes
Kyriakos Anastasiadis 
Aristoteleio Panepistimio Thessalonikis: Aristoteleio Panepistemio Thessalonikes

Research article

Keywords: physiotherapy, open heart surgery, early mobilization, enhanced physiotherapy, coronary artery
bypass grafting, active physiotherapy, randomized-controlled trial

Posted Date: November 16th, 2021

DOI: https://doi.org/10.21203/rs.3.rs-1051420/v1

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Abstract
Objective: This randomized controlled trial aimed to investigate the influence of physical activity and
respiratory physiotherapy on zero postoperative day on clinical, hemodynamic and respiratory
parameters of patients undergoing cardiac surgeries under extracorporeal circulation.

Methods: 78 patients undergoing coronary artery bypass graft (CABG) or/and valvular heart disease
surgeries were randomly assigned into active physiotherapy group (APG; n=39) and conventional
physiotherapy group (CPG; n=39). Treatment protocol for APG included ≤3 Mets of physical activity and
respiratory physiotherapy on zero post-operative day and an extra physiotherapy session during the first
three post-operative days, whereas CPG was treated with usual physiotherapy care after the first post-
operative day. The length of hospital and intensive care unit (ICU) stay were set as the primary study
outcomes, while pre- and post-intervention measurements were also performed to assess the oxymetric
and hemodynamic influence of early mobilization and physiotherapy.

Results: Participants’ mean age was 51.86 ±13.76 years. Of them 48 (61.5%) underwent CABG. Baseline
and peri-procedural characteristics did not differ between the 2 groups. The total duration of hospital and
ICU stay were significantly higher in the CPG compared to the APG (8.1±0.4 versus 10.2±0.6 days and
32.1±1.7 versus 23.2±0.6 hours, p<0.001, respectively). Statistically significant differences in pre-
intervention oxygen saturation, and post-intervention PO2 and lactate levels were also observed between
the 2 groups (p=0.022, 0.027 and 0.001, respectively).

Conclusion: In on-pump cardiac surgery, early and active post-procedural physical activity (≤3 METS) can
prevent prolonged ICU stay and decrease the duration of hospitalization whilst ameliorating post-
operative hemodynamic and oxymetric parameters.

Introduction
Millions of patients benefit annually from open heart surgery, while the actual number of such operations
in western countries remains stable over the last decade, despite the current advancements in
cardiovascular medicine, offering pharmacological or minimally invasive alternatives[1, 2]. However, open
heart surgeries are still associated with increased risk for cardiovascular morbidity, respiratory
complications and prolonged length of intensive care unit (ICU) stay and hospitalization, which increases
the financial healthcare burden[3]. Concurrently, physiotherapy and early physical activity have been
considered as crucial factors with a seemingly positive impact on post-procedural functional capacity,
muscle weakness, prevention or mitigation of post-operative complications succeeding heart surgery, and
thereby leading to quality of life amelioration[4].

Nevertheless, despite the apparent sequelae of reduced mobility and subsequent muscle weakness in
patients undergoing open heart surgery, the effect of the extent and timing of early respiratory
physiotherapy and mobilization on the length of ICU stay in cardiothoracic patients, has not been
thoroughly investigated[5]. Furthermore, significant variability exists in physiotherapy strategies and early
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mobilization practices[6]. Several studies have attempted to examine whether physiotherapy and
rehabilitation might be an effective non-pharmacological tool to improve post-operative outcomes and
reduce hospitalization stay[7–11]. Nonetheless, none of them investigated the influence of
intensified/intensive post-operative physiotherapy and rapid mobilization.

On the basis of the above, we conducted a randomized-controlled trial to investigate the influence of
enhanced post-operative physiotherapy and mobilization on patients undergoing open heart surgery. In
particular, we aimed to inquire into the potential impact of early mobilization and physical activity
combined with extra sessions of active post-operative physiotherapy, on the duration of ICU stay and
hospitalization, as well as on clinical and laboratory parameters following open heart surgery.

Methods
Study Design and Sample Size Calculation
A double-blinded randomized clinical trial was designed to investigate the effect of respiratory
physiotherapy and early mobilization and exercise on patients undergoing cardiac surgery [coronary
artery bypass grafting (CABG) or valvular surgery] under extracorporeal circulation. The protocol of the
study and all trial procedures conformed to the CONSORT Statement recommendations for reporting
randomized trials[12].

Based on a minimum effect size of interest approach to calculate the sample size required to detect a
statistically significant difference between the intervention group and the control group in terms of the
primary outcome, 80 study participants (40 in each group) were required to have a 90% power to detect
the effect at a significance level of 0.05.

Study Participants and Eligibility Criteria

Patients admitted to the University Cardiothoracic Surgical Departments of the University Hospitals of
Thessaly and Thessaloniki between February 2019 and December 2020 to undergo elective CABG or
valvular surgery with cardiopulmonary bypass were randomly allocated to control group (CPG) or active
physiotherapy group (APG) to be included in this trial.

Patients of both genders were invited to participate in this study without any race limitation. The
inclusion criteria consisted of: i. a written informed consent to participate in the study, ii. a Glasgow Coma
Scale score=15, as well as iii. musculoskeletal, and cardiopulmonary conditions suitable for the
accomplishment of the proposed activities. On the contrary, patients were excluded from the study if they
met one or more of the following criteria: i. emergency, non-elective cardiac surgery ii. hemodynamic
instability preventing protocol performance, iii. breathing discomfort or invasive ventilator support or
oxygen saturation below 90%, iv. severe neurological sequelae or neurodegenerative disorders, and v. any
mobile disability that did not permit to perform exercise according to our protocol.

Random Allocation and Blinding

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Patients were randomly assigned to an APG (n=39) or to a CPG (n=39). Eligible participants were
allocated in each group in turn, according to the date of hospital admission. The anaesthesia, peri- and
post-surgical management procedures were standardised for all patients (ECMO: Medtronic Performer
CPB, Oxygenation System: Medtronic Affinity NT, Autotransfusion System: Medtronic Autolog IQ, Heater-
Cooler System: Stockert Basic Heater-Cooler Unit, Online Monitoring System: Spectrum Medical System M,
Intra-Aortic Balloon Pump: Maquet Datascope GS300, Blood Flow Meter: Medistim MiraQ™ system, post-
excubation: Venturi mask 50% oxygen flow rate) and were performed by the same team of Cardio-
thoracic surgeons and Emergency and Critical Care technicians in the cardiothoracic surgery department
of general university hospital of Larissa

The study was a double-blinded trial so that the participants were unaware of the existence of the other
group. The blinded researcher was also not aware of the group of patients; whether they were in the CPG
or in the APG. After collecting the data, the blinded researcher measured the defined outcomes of interest.

Intervention
Usual physiotherapy care was applied to participants of the CPG twice a day commencing on the first
post-operative day until their discharge. This routine physiotherapy care included deep breathing
exercises, coughing, limb mobility exercises on bed, incentive spirometer, chest percussion, and 10 to 50
steps of walk, twice a day. On the contrary, patients, allocated to the APG group, were provided with an
extra physiotherapy session during first three post-operative days or until ICU discharge.

Except for the aforementioned enhanced physiotherapy strategy, patients of the APG also received an
early physiotherapy session performed during zero post-operative day in the ICU. This early and active
physiotherapy strategy involved early mobilization and physical activity along with chest physiotherapy
on zero postoperative day, as described below:

1. Respiratory physiotherapy included guided deep breathing techniques, utilization of the TriFlo
Inspiratory Exerciser, incentive spirometer exercises, chest splinting by cushion, chest binder or using
passive assistance of physical therapist, and patients were instructed to cough out, accompanied by
moderate intensity chest percussion as per requirement.
2. Physical activity consisted of supported sitting over the edge of bed at bed side, performed on the
first hours after extubation, assisted by the Subsequently, patients were mobilized out of bed
standing for 1-2 minutes and 10 steps of static walk, along with deep breathing exercises, followed
by sitting on the chair beside bed for half an hour, thereby achieving an estimated energy expenditure
of no more than 3 metabolic equivalents of physical activity.

Briefly, the APG intervention comprised of an early mobilization and physiotherapy strategy during zero
post-operative day, and an extra physiotherapy session taking place in the afternoon of the first three
post-operative days or until ICU discharge. All physiotherapy interventions were undertaken by trained
physiotherapists who were unaware of the existence of 2 study groups and were also assisted by nurses
and doctors of the ICU.

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Ethical Considerations
The study protocol has been approved by the Institutional Review Board of Aristotle University of
Thessaloniki, and the trial was conducted in compliance with the principles stated by the Declaration of
Helsinki.

Recorded variables and measurements performed

The measurements detailed in this section were taken before and after completion of the APG
physiotherapy protocols on zero post-operative day. Despite no physiotherapy session was performed in
the CPG on zero post-operative day, the following hemodynamic and laboratory measurements, as well
as clinical and demographic parameters were also recorded for the CPG, aiming to perform inter-group
comparison analyses. After admission to the ICU, arterial and central venous, and mixed venous blood
samples were taken to accomplish these hemodynamic and laboratory measurements.

The demographics included data on: gender, age, body mass index (BMI) and cardiac surgery performed.
Hemodynamic measurements included monitoring of body temperature, heart rate, respiratory rate, blood
pressure, and oxygen saturation. Laboratory measurements consisted of serum electrolytes (Ca2+, Na+,
K+), glucose and hemoglobin values as well as arterial blood gas analyses (pH, SvO2, PO2, PCO2, HCO3
and lactate). Echocardiographic and electrocardiographic assessment has been also performed in every
participant to record baseline left ventricular ejection fraction (LVEF) values via the Modified Simpson
method (biplane method of disks) and to document the occurrence of any cardiac arrhythmia,
respectively.

Further procedure-related data have been recorded to perform relevant inter-group comparisons. In
particular, we documented: length of hospital stay (in days), length of ICU stay (in hours), duration of
extracorporeal membrane oxygenation (ECMO) and aortic cross-clamp time (in minutes), number of
coronary artery grafts as well as units of red blood cells (RBC) and fresh frozen plasma (FFP) transfused.

Definition of study outcomes

The primary outcome of this study was to identify any existing difference in the length of hospital and
ICU stay between participants of the APG and those of the CPG. Secondary outcomes of interest were the
comparisons of hemodynamic and laboratory measurements between the 2 study groups to detect any
difference according to the physiotherapy protocol applied.

Statistical analysis
Categorical variables are presented as frequencies with percentages, and continuous ones as means with
standard deviations. Comparison among categorical variables was performed via the Pearson chi-square
or Fisher's exact test, whereas the Wilcoxon rank-sum or Student's t-test were used to compare continuous
variables, depending on the normality of data distributions. All analyses were conducted with the SPSS
Statistics for Windows, Version 24.0 (Armonk, NY: IBM Corp) and a two-sided p value of less than 0.05
was considered as statistically significant.
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Results
After applying the inclusion and exclusion criteria, 78 patients (65 men, 13 women; mean age: 64.3±8.9
years old) were finally included in this study among the 90 patients initially assessed for eligibility. Four
patients died during surgery, three surgeries were cancelled and three surgeries were performed without
the use of extracorporeal circulation and two patients refused to participate in the study. Figure 1
describes the flowchart of patient participation; 39 patients were randomly allocated to the APG and 39
others to the CPG.

The baseline, pre- and post-operative data are summarized in Table 1 and show that after randomization,
the two groups had similar characteristics regarding gender, age, and BMI. Surgical procedure data were
also comparable between groups, demonstrated by similar ECMO time, aortic cross clamp time, type of
surgery performed, number of coronary artery grafts and units of RBC and FFP transfused (all p-
values>0.05).

Table 1
Baseline demographic and clinical characteristics of study participants
Variable APG (n=39) CPG (n=39) p-value

Age (years) 63.5 ± 8.9 65.1 ± 8.9 0.424

Male gender, n (%) 34 (87.2%) 31 (79.5%) 0.362

Body mass index (kg/m2) 26.8 ± 4.2 27.9 ± 4.2 0.234

Left Ventricular Ejection Fraction (%) 50±6 49.7±6.5 0.856

Type of surgery:      

Coronary artery bypass graft, n (%) 25 (64.1%) 23 (59%) 0.119

Aortic valve replacement, n (%) 9 (23.1%) 15 (38.5%)

Mitral valve replacement, n (%) 5 (12.8%) 1 (2.5%)

Coronary artery grafts (number) 3.1±0.8 3±0.8 0.593

Red blood cells transfused (units) 0.9±0.9 0.5±0.7 0.063

Fresh frozen plasma transfused (units) 1.9±1.1 1.9±1.2 0.772

Cardiopulmonary bypass time (CBT) (minutes) 100.1±21.3 99±27.7 0.848

Aortic cross-clamp time (minutes) 68.5±19.1 69.7±19.5 0.770

 

With regard to the primary outcome of this study (Table 2; Figure 2), patients of the APG had to stay in
hospital for significantly less days than patients of the CPG (8.1±0.4 versus 10.2±0.6, p<0.001) after their
surgery. The total duration of ICU stay was also significantly higher in the CPG compared to the APG

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(32.1±1.7 hours versus 23.2±0.6 hours, p<0.001). Sub-analysis on the length of hospital and ICU stay
according to the type of surgery performed did not demonstrate any significant difference (ANOVA:
p=0.590 and 0.327, respectively).

Table 2
Comparison of primary outcome parameters
Variable APG(n=39) CPG (n=39) P value

Length of hospital stay after surgery (days) 8.1±0.4 10.2±0.6 <0.001

Length of stay in the intensive care unit (hours) 23.2±0.6 32.1±1.7 <0.001
 

The comparison of pre- and post-intervention laboratory, oxymetric and hemodynamic measurements
between the 2 study groups is presented in Table 3 and yielded that most of the measurements did not
differ significantly. In particular, pre- and post-intervention sodium, potassium, calcium, glucose,
hemoglobin values were almost similar among the 2 groups (p-values>0.05) with an existing non-
significant trend towards higher glucose levels in the CPG than those of the APG (pre-intervention:
153.5±39.1 mg/dl versus 140.6±25 mg/dl, p=0.087; and post-intervention: 156.8±33.5 mg/dl versus
146±24.1 mg/dl, p=0.105). Analyses on the observed respiratory rates, blood pressure levels, body
temperatures, venous oxygen saturation, arterial blood pH and PCO2 levels did not yield any significant
differentiation (p-values>0.05). However, mean arterial oxygen saturation was significantly higher in the
CPG prior to the intervention (99% versus 98.1%, p=0.022) but non-significantly lower than that of the
APG after the intervention (99% versus 99.4%, p=0.128). Finally, mean PO2 levels were significantly higher
in the APG than in the CPG after the intervention (192.5±70.8 mmHg versus 159±60.2, p=0.027), whereas
mean post-intervention lactate levels were significantly higher in the CPG when compared to those in the
APG (1.5±0.7 mmol/L versus 1.1±0.2 mmol/L, p=0.001).

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 Table 3
Comparison of pre- and post-intervention laboratory, oximetric and hemodynamic
measurements
Variable APC CPG p-value

(n=39) (n=39)

Na+ (mEq/L):      

Pre-intervention 137.3±2.6 139.1±6.6 0.105

Post-intervention 137.6±3 137.6±2.8 0.995

K+ (mmol/L):      

Pre-intervention 4.0±0.4 4.0±0.7 0.729

Post-intervention 4.1±0.3 4.1±0.3 0.968

Ca2+ (mg/dl):      

Pre-intervention 0.9±0.3 0.9±0.1 0.293

Post-intervention 0.9±0.2 0.9±0.1 0.488

Glucose (mg/dl):      

Pre-intervention 140.6±25 153.5±39.1 0.087

Post-intervention 146±24.1 156.8±33.5 0.105

Hemoglobin (g/dl):      

Pre-intervention 9.6±0.98 9.6±0.9 0.813

Post-intervention 9.8±1 9.8±0.9 0.972

Respiratory rate (breaths per      

minute):
23.4±2.7 24.3±2.9 0.183
Pre-intervention
24.3±2.8 24.9±1.7 0.263
Post-intervention

Systolic arterial pressure (mmHg):      

Pre-intervention 130.4±14.2 127.1±16 0.329

Post-intervention 130.6±15.2 130.3±15.7 0.942

Diastolic arterial pressure      

(mmHg):
59.1±8.5 63.9±19.8 0.167
Pre-intervention
59.8±8 59.3±9.9 0.803
Post-intervention

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 Variable APC CPG p-value

(n=39) (n=39)

Body temperature (oC):      

Pre-intervention 36.4±2.3 36.8±0.4 0.216

Post-intervention 37±0.4 36.9±0.3 0.424

Arterial oxygen saturation (%):      

Pre-intervention 98.1±1.9 99±1.2 0.022

Post-intervention 99.4±1 99±1.2 0.128

Venous oxygen saturation (%):      

Pre-intervention 61.8±6.8 58.4±9 0.187

Post-intervention 65.2±6.9 61.1±9.4 0.141

Arterial blood pH (pH):      

Pre-intervention 7.4±0.03 7.4±0.04 0.954

Post-intervention 7.4±0.04 7.4±0.04 0.951

PCO2 (mmHg):      

Pre-intervention 40.9±4.3 40±4 0.347

Post-intervention 40.6±4.9 40.9±4.3 0.787

PO2 (mmHg):      

Pre-intervention 137.5±63.8 149.4±68.3 0.430

Post-intervention 192.5±70.8 159±60.2 0.027

Lactate (mmol/L):      

Pre-intervention 1.5±0.6 1.6±0.7 0.694

Post-intervention 1.1±0.2 1.5±0.7 0.001

Discussion
In this randomized-controlled trial enrolling patients undergoing selective open heart surgery, application
of early and enhanced physiotherapy conferred an advantage in the length of hospital and ICU stay over
a conventional physiotherapy strategy. In addition, our study indicated a statistically significant
difference in mean post-intervention PO2 between APG and CPG, in favour of active and enhanced
physiotherapy. Our study adds to the existing literature as most of the studies dealt with enhanced
sessions of physiotherapy after the first post-operative day or ICU discharge, or with enhanced pre-
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operative physical activity. To our knowledge, this is the first study to compare, in terms of hospitalization
length, a conventional physiotherapy strategy with an active physiotherapy, which included enhanced
post-operative physical activity along with early mobilization. Of note, no adverse outcomes, such as
oxygen desaturation, hypotension, acute coronary events, and arrhythmias were observed during
protocols application.

Our results are consistent with those of other studies[8, 9, 13, 14] indicating that early mobilization can
decrease hospitalization length. Furthermore, a meta-analysis conducted by Y. Kanejima et al suggested
that early mobilization after cardiac surgery might improve physical function at discharge and
subsequently prevent prolonged hospital stays[11]. For a patient undergoing open heart surgery, days
spent in the ICU, as well as the next three ones, constitute the most critical time of their post-operative
phase[15]. Multiple organs, with lungs being of outmost importance, are prone to dysfunction during this
period[16].

After open heart surgery, deterioration of functional capacity can be triggered by muscle weakness and
proteolysis, induced by reduced mobility. Prolonged inactivity and muscle atrophy are responsible for
atelectasis, sensation of fatigue and aspiration pneumonia, which render rehabilitation a ‘highly
recommended’ healthcare strategy in post-operative period of invasive cardiac procedures[17–19].
Therefore, the presence of a multi-professional team including physiotherapists in the ICU is proven by
several studies to contribute to early patient recovery, reduced mechanical ventilation support need, and
ultimately less number hospitalization days, by preventing respiratory complications[20].

On the other hand, some studies on post-operative ICU patients have questioned these outcomes and
highlighted the absence of apparent differences between early mobilization and usual care[21, 22]
regarding the length of hospitalization. Furthermore, no study has indicated survival benefits for APG
patients, and thus a decreased hospitalization length does not seem to be translated into lower rates of
all-cause mortality or/and cardiovascular mortality[22]. This is also supported by the fact that the effects
of early and active physiotherapy are not reflected on changes in hemodynamic and laboratory
indicators[7]. This is in harmony with our results, which only yielded a significant difference in post-
operative PO2 and lactate levels between APG and CPG.

Despite not having a clinically significant effect, in terms of hard clinical outcomes and laboratory
parameters, active and early physiotherapy could still play a crucial role in reducing healthcare costs and
decongesting ICUs. Indeed, another study, with original data deriving from a large registry, also showed
that early cardiac rehabilitation was associated with a lower length of ICU and hospital stay, and by such
means significantly reduced costs[13].

Our study should be interpreted in the context of its limitations. First of all, our randomized-controlled trial
is single centred with a relatively limited number of included patients. Further, we were not capable of
thoroughly elucidating our results in a pathophysiological basis, as well as providing clinical
explanations about the fact that decreased hospitalization and ICU stay was not translated to altered
hemodynamic and laboratory parameters. Moreover, we did not incorporate and analyze any techniques
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of pre-operative physiotherapy. Finally, our results demonstrated the effect of a combined intervention,
which included both early mobilization and enhanced physiotherapy sessions. However, we were not able
to separately assess the clinical weight and significance of each intervention on our outcomes. Future
clinical studies could test different combinations of physiotherapy and mobilization activities to form the
most cost-effective physiotherapy strategy after open heart surgery, which could optimally be based on
the clinical parameters of each patient, thereby providing a personalized approach in cardiovascular
physiotherapy.

Conclusion
In patients undergoing open heart surgery, early mobilization and physical activity along with enhanced
respiratory physiotherapy significantly decreased both ICU and hospitalization stay. However, these
outcomes were not reflected on significant differences in post-intervention hemodynamic and laboratory
parameters, except for increased PO2 and decreased lactate levels. Larger randomized-controlled trials
are warranted to establish certain physiotherapy strategies and a structured physiotherapy program,
which might lead to better clinical outcomes and faster postoperative recovery, decreasing the length of
hospitalization and the subsequent financial healthcare burden.

Declarations
-Ethics approval and consent to participate: The study protocol has been approved by the Institutional
Review Board of Aristotle University of Thessaloniki, and the trial was conducted in compliance with the
principles stated by the Declaration of Helsinki.

-Consent for publication: Obtained from every patient; available at request

-Availability of data and materials: The datasets during and/or analysed during the current study
available from the corresponding author on reasonable request.

-Competing interests: The authors declare that they have no competing interests

-Funding: None

-Authors' contributions: GA and KA conceived the project, performed the trial and were the principal
investigators, DVM, ASD and CT collected the data and wrote the manuscript, AL and IAA analyzed and
interpreted the patient data and reviewed the manuscript, CF and GTK supervised the trial.

-Acknowledgements: Not applicable

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Figures

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Figure 1

Flowchart of patient participation in this randomized controlled trial according to the CONSORT 2010
statement guidelines

Figure 2

Bar plots presenting: The mean length of hospital stay (in days) and the mean length of ICU stay (in
hours) by: the 2 study groups (2A and 2B) and the type of surgery performed (2C and 2D).

Supplementary Files
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PhysiotherapyOpenheartsurgery.png

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