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

National Yang Ming Chiao Tung University

Status: Unknown

Conditions: Other Functional Disturbances Following Cardiac Surgery

Treatments: Behavioral: Traditional CPT; Behavioral: Pilates-based CPT

Study type: Interventional

Funder types: Other

Identifiers

NCT02437240

NationalYangMingU

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Pilates-based CPT

Experimental group

Description:

incorporated the concept of pilates training into cardiopulmonary physical therapy after cardiac surgery

Treatment:

Behavioral: Pilates-based CPT

Traditional CPT

Active Comparator group

Description:

usual bed side cardiopulmonary physical therapy after cardiac surgery

Treatment:

Behavioral: Traditional CPT