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Clinical Trials/NCT02437240
NCT02437240
Unknown
Not Applicable

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

National Yang Ming Chiao Tung University0 sites140 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Other Functional Disturbances Following Cardiac Surgery
Sponsor
National Yang Ming Chiao Tung University
Enrollment
140
Primary Endpoint
change from pre-operation in respiratory mechanics
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
July 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mei-Wun Tsai

Associate Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

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

Outcomes

Primary Outcomes

change from pre-operation in respiratory mechanics

Time Frame: 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 Outcomes

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

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