Other Functional Disturbances Following Cardiac Surgery
Conditions
Keywords
Pilates-based exercise, respiratory mechanics, cardiopulmonary physical therapy, sternotomy
Brief summary
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
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.
Interventions
BEHAVIORALPilates-based CPT
To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery
BEHAVIORALTraditional CPT
A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on
Sponsors
Cheng-Hsin General Hospital
National Yang Ming Chiao Tung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from pre-operation in respiratory mechanics | at hospital discharge, an expected average of 2 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from pre-operation in chest mobility | at hospital discharge, an expected average of 2 weeks after surgery | 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. |
| abnormal breathing pattern | at hospital discharge, an expected average of 2 weeks after surgery | 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. |
| Percentage change from preoperative pulmonary function | at hospital discharge, an expected average of 2 weeks after surgery | 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 |
| change from pre-operation in respiratory mechanics | at 6 month after surgery | 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. |
| cardiopulmonary exercise function | at one month after hospital discharge | Symptom-limited graded exercise testing is used to assess cardiopulmonary exercise function at one month after hospital discharge. |
| health related quality of life | at 6 month after hospital discharge | Cardiovascular Limitations and Symptoms Profile (37 items) is used to assess disease specific health related quality of life at 6 month after hospital discharge. |
| change of cardiopulmonary fitness | at hospital discharge, an expected average of 2 weeks after cardiac surgery | Six-minute walking test is used to assess cardiopulmonary fitness at hospital discharge, an expected average of 2 weeks after cardiac surgery. |
Outcome results
None listed