Effects of Breathing Retraining in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: respiratory biofeedback

• Registration Number: NCT01175265
• Lead Sponsor: University Hospital, Essen

Brief Summary

Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle strength, and health related quality of live but not pulmonary function in patients with chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in this study is that pulmonary function, cardio-pulmonary exercise capacity, health related quality of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary rehabilitation plus breathing retraining will be better than that of patients undergoing a conventional pulmonary rehabilitation.

Detailed Description

To address this uncertainty, we performed a randomized controlled trial to assess the effects of a 4-week rehabilitation program including breathing retraining on pulmonary function (PFT), cardio-pulmonary exercise capacity (CPET), health related quality of life (HRQL) and cardiac autonomic modulation (CAM).

A randomized controlled trial comparing the effects of a conventional 4-week pulmonary rehabilitation program with those of a 4-week pulmonary rehabilitation program plus breathing retraining on pulmonary function (FEV1), cardiopulmonary exercise capacity (6-minute walking distance, 6MWD), health related quality of life (chronic respiratory questionnaire, CRQ) and cardiac autonomic function (rMSSD) was performed.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-08
• Status Verified: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-08-03
• Last Update Submitted: 2010-08-03
• Study First Posted: 2010-08-04
• Last Update Posted: 2010-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinically stable patients with COPD (GOLD-classification I-IV)

Exclusion Criteria

• Patients with clinical signs of COPD exacerbation
• Cardiac arrhythmia
• Coronary artery disease
• Primary pulmonary vascular disease
• Oxygen desaturation to less than 80% during exercise on room air

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
breathing retraining	respiratory biofeedback	Forty COPD patients (23 females) with a mean (SD) age of 66.0 (6.3) years and a FEV1 of 47.1 (18.9) % predicted were randomized to conventional pulmonary rehabilitation (n=20) and conventional pulmonary rehabilitation plus breathing retraining (n=20).

Primary Outcome Measures

Name	Time	Method
cardiopulmonary exercise capacity		6-minute walking distance, 6MWD

Secondary Outcome Measures

Name	Time	Method
pulmonary function		pulmonary function (FEV1)
quality of life		health related quality of life (chronic respiratory questionnaire, CRQ)
autonomic function		cardiac autonomic function (rMSSD)

Trial Locations

Locations (1)

University Hospital Ruhrlandklinik; 🇩🇪 Essen, Nordrheinwestfalen, Germany