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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01175265
First received: July 13, 2010
Last updated: August 3, 2010
Last verified: April 2010
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • cardiopulmonary exercise capacity [ Designated as safety issue: Yes ]
    6-minute walking distance, 6MWD


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175265

Locations
Germany
University Hospital Ruhrlandklinik
Essen, Nordrheinwestfalen, Germany, 45239
Sponsors and Collaborators
University Hospital, Essen
Investigators
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 July 26, 2014