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

Effects of Breathing Retraining on Pulmonary Function, Exercise Capacity, Quality of Life and Cardiac Autonomic Function in Patients With COPD

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: respiratory biofeedback

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrheinwestfalen
    • Essen, Nordrheinwestfalen, Germany, 45239
      • University Hospital Ruhrlandklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
cardiopulmonary exercise capacity	6-minute walking distance, 6MWD

Secondary Outcome Measures

Outcome Measure	Measure Description
pulmonary function	pulmonary function (FEV1)
quality of life	health related quality of life (chronic respiratory questionnaire, CRQ)
autonomic function	cardiac autonomic function (rMSSD)

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Investigators: Study Director: Helmut Teschler, Prof. Dr. dipl Ing, Ruhlrandklink Essen

Publications and helpful links

General Publications

• van Gestel AJ, Kohler M, Steier J, Teschler S, Russi EW, Teschler H. The effects of controlled breathing during pulmonary rehabilitation in patients with COPD. Respiration. 2012;83(2):115-24. doi: 10.1159/000324449. Epub 2011 Apr 7.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (Estimate): August 4, 2010

Study Record Updates

• Last Update Posted (Estimate): August 4, 2010
• Last Update Submitted That Met QC Criteria: August 3, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: quality of life; COPD; exercise capacity; pulmonary rehabilitation; pulmonary function; clinically stable; COPD (GOLD-classification I-IV); breathing retraining; cardiac autonomic function
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
• Other Study ID Numbers: FDAAA