Overview

This trial is active, not recruiting.

Condition other functional disturbances following cardiac surgery
Treatments pilates-based cpt, traditional cpt
Sponsor National Yang Ming University
Collaborator Cheng-Hsin General Hospital
Start date August 2014
End date February 2017
Trial size 140 participants
Trial identifier NCT02437240, NationalYangMingU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
incorporated the concept of pilates training into cardiopulmonary physical therapy after cardiac surgery
pilates-based cpt
To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery
(Active Comparator)
usual bed side cardiopulmonary physical therapy after cardiac surgery
traditional cpt
A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on

Primary Outcomes

Measure
change from pre-operation in respiratory mechanics
time frame: at hospital discharge, an expected average of 2 weeks after surgery

Secondary Outcomes

Measure
change from pre-operation in respiratory mechanics
time frame: at 6 month after surgery
change from pre-operation in chest mobility
time frame: at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
time frame: at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
time frame: at 6 month after surgery
Percentage change from preoperative pulmonary function
time frame: at hospital discharge, an expected average of 2 weeks after surgery
Percentage change from preoperative pulmonary function
time frame: at 6 month after surgery
change of cardiopulmonary fitness
time frame: at hospital discharge, an expected average of 2 weeks after cardiac surgery
cardiopulmonary exercise function
time frame: at one month after hospital discharge
health related quality of life
time frame: at 6 month after hospital discharge

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Effects of Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by National Yang Ming University.