Effects of Breathing Retraining in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Other: respiratory biofeedback |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effects of Breathing Retraining on Pulmonary Function, Exercise Capacity, Quality of Life and Cardiac Autonomic Function in Patients With COPD |
- cardiopulmonary exercise capacity [ Designated as safety issue: Yes ]6-minute walking distance, 6MWD
- pulmonary function [ Designated as safety issue: Yes ]pulmonary function (FEV1)
- quality of life [ Designated as safety issue: Yes ]health related quality of life (chronic respiratory questionnaire, CRQ)
- autonomic function [ Designated as safety issue: Yes ]cardiac autonomic function (rMSSD)
| Enrollment: | 40 |
| Study Start Date: | November 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: pulmonary rehabilitation, no breathing retraining
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).
|
|
|
No Intervention: breathing retraining
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).
|
Other: respiratory biofeedback
In order to train effortless diaphragmatic breathing techniques the biofeedback loop starts at the sensor that measures the patient's breathing rhythm at both umbilical and abdominal level. The sensor is connected to an amplifier that converts the electrical impulses into acoustical and visual outputs. Patients were encouraged to regulate their breathing patterns at a 10-20% slower respiration rate resulting in increased tidal volumes. Furthermore, the patients were encouraged to reduce dynamic hyperinflation by completing the expiration prior to the initiation of the next breath while using pursed-lips breathing. Patients were trained to breath as comfortable as possible with predominant abdominal expansion during the inhalation and smooth abdominal contraction during exhalation.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Germany | |
| University Hospital Ruhrlandklinik | |
| Essen, Nordrheinwestfalen, Germany, 45239 | |
| Study Director: | Helmut Teschler, Prof. Dr. dipl Ing | Ruhlrandklink Essen |
More Information
No publications provided by University Hospital, Essen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Dr. dipl. Ing. H. Teschler, Ruhrlandklinik |
| ClinicalTrials.gov Identifier: | NCT01175265 History of Changes |
| Other Study ID Numbers: | FDAAA |
| Study First Received: | July 13, 2010 |
| Last Updated: | August 3, 2010 |
| Health Authority: | Germany: the German Thoracic Society (DGP) |
Keywords provided by University Hospital, Essen:
|
clinically stable COPD (GOLD-classification I-IV) COPD breathing retraining pulmonary rehabilitation |
cardiac autonomic function quality of life exercise capacity pulmonary function |
Additional relevant MeSH terms:
|
Respiratory Aspiration Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013