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

NCT ID: NCT01175265

Last Updated: 2010-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-04-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

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

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: NO_INTERVENTION

respiratory biofeedback

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Ruhrlandklinik

Principal Investigators

Helmut Teschler, Prof. Dr. dipl Ing

Role: STUDY_DIRECTOR

Ruhlrandklink Essen

Locations

University Hospital Ruhrlandklinik

Essen, Nordrheinwestfalen, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 21474911 (View on PubMed)

Other Identifiers

FDAAA

Identifier Type: -

Identifier Source: org_study_id