Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery.

Detailed Description
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Postoperative pulmonary and musculoskeletal complications are the most frequent and significant contributor to morbidity, mortality with hospitalization. Pilates-based exercise has be applied to improve core control, movement efficiency and postural stability. High incidence of musculoskeletal problems have been concerned in relation to the patient's functional recovery after cardiac surgery. However, no literature is addressed how to manage this issue effectively till now. The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy for in-patients after cardiac surgery. This is a single-blinded, randomized control trial. Investigators will enroll pre-cardiac surgery and allocate subjects to modified Pilates-based training group or control group using block randomization.The training protocol will be based on pilates concepts. The control group is treated with a conventional protocol of physical therapy. The study will be carried on whole in-patient phase. During this period, patients received respiratory motion analysis, chest wall muscles mobility, lung function and endurance evaluation. Patients' changes in respiratory movement, cardiopulmonary endurance, and lung function will be evaluated by an assessor blinded to the intervention at admission and discharge from hospital. After 6 months after hospital discharge, patient's respiratory motion, lung function and disease specific health related quality of life will be evaluated. All outcomes will be described by mean (SD) or number (%). Independent t test or chi square test will be used to compare the basic data difference between training group and conventional group. Then, two-way analysis of variance or two-way analysis of covariance will be used to compare the outcomes difference between groups. Alpha level is set at 0.05.

Official Title
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Effects of Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery

Conditions
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Other Functional Disturbances Following Cardiac Surgery

Intervention / Treatment
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* Behavioral: Pilates-based CPT
* Behavioral: Traditional CPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: post open heart surgery FVC> 80% of predicted and/or FEV1>70% of predicted age >/=20 years old approve inform consent Exclusion Criteria: preoperative severe pulmonary hypertension moderate to severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease heart failure or s/p heart transplant emergent surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates-based CPT<br>incorporated the concept of pilates training into cardiopulmonary physical therapy after cardiac surgery | Behavioral: Pilates-based CPT<br>* To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery<br>|
| Active Comparator: Traditional CPT<br>usual bed side cardiopulmonary physical therapy after cardiac surgery | Behavioral: Traditional CPT<br>* A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from pre-operation in respiratory mechanics | Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery. | at hospital discharge, an expected average of 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from pre-operation in respiratory mechanics | Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at 6 month after surgery. | at 6 month after surgery | 
| change from pre-operation in chest mobility | Chest mobility will be assessed by tape measuring the difference of chest circumference between deep inspiration and expiration. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery. | at hospital discharge, an expected average of 2 weeks after surgery | 
| abnormal breathing pattern | Abnormal breathing pattern will be assessed by physical examination and camera recording if there is any paradoxical, asymmetrical chest movements during breathing. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery. | at hospital discharge, an expected average of 2 weeks after surgery | 
| abnormal breathing pattern | Abnormal breathing pattern will be assessed by physical examination and camera recording if there is any paradoxical, asymmetrical chest movements during breathing. Participants will be followed at 6 month after surgery. | at 6 month after surgery | 
| Percentage change from preoperative pulmonary function | Percentage of preoperative pulmonary function, including forced vital capacity (FVC), the first second forced expiratory volume (FEV1), peak inspiratory flow and peak expiratory flow are measured by spirometry at hospital discharge, an expected average of 2 weeks after cardiac surgery | at hospital discharge, an expected average of 2 weeks after surgery | 
| Percentage change from preoperative pulmonary function | Percentage of preoperative pulmonary function, including forced vital capacity (FVC), the first second forced expiratory volume (FEV1), peak inspiratory flow and peak expiratory flow are measured by spirometry at 6 month after surgery | at 6 month after surgery | 
| change of cardiopulmonary fitness | Six-minute walking test is used to assess cardiopulmonary fitness at hospital discharge, an expected average of 2 weeks after cardiac surgery. | at hospital discharge, an expected average of 2 weeks after cardiac surgery | 
| cardiopulmonary exercise function | Symptom-limited graded exercise testing is used to assess cardiopulmonary exercise function at one month after hospital discharge. | at one month after hospital discharge | 
| health related quality of life | Cardiovascular Limitations and Symptoms Profile (37 items) is used to assess disease specific health related quality of life at 6 month after hospital discharge. | at 6 month after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilates-based exercise, respiratory mechanics, cardiopulmonary physical therapy, sternotomy