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

NCT ID: NCT02437240

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-07-31

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.

Conditions

Other Functional Disturbances Following Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pilates-based CPT

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

Group Type: EXPERIMENTAL

Pilates-based CPT

Intervention Type: BEHAVIORAL

To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery

Traditional CPT

usual bed side cardiopulmonary physical therapy after cardiac surgery

Group Type: ACTIVE_COMPARATOR

Traditional CPT

Intervention Type: BEHAVIORAL

A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on

Interventions

Pilates-based CPT

To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cheng-Hsin General Hospital

OTHER

Sponsor Role: collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Mei-Wun Tsai

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

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Related Links

http://WWW.UPTODATE.COM

Postoperative complications among patients undergoing cardiac surgery

Other Identifiers

NationalYangMingU

Identifier Type: -

Identifier Source: org_study_id