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

NCT01175265 | Completed Phase 1 DMC

• 1 other identifier: FDAAA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

clinically stable; COPD (GOLD-classification I-IV); COPD; breathing retraining; pulmonary rehabilitation; cardiac autonomic function; quality of life; exercise capacity; pulmonary function

Outcome Measures

Primary Outcomes (1)

• cardiopulmonary exercise capacity

  6-minute walking distance, 6MWD

Secondary Outcomes (3)

• pulmonary function

• quality of life

• autonomic function

Study Arms (2)

pulmonary rehabilitation, no breathing retraining

NO INTERVENTION

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).

breathing retraining

NO INTERVENTION

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

Interventions

respiratory biofeedback 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.

breathing retraining

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Ruhrlandklinik

Essen, Nordrheinwestfalen, 45239, Germany

Location

Related Publications (1)

• 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.

  PMID: 21474911 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helmut Teschler, Prof. Dr. dipl Ing

  Ruhlrandklink Essen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: August 4, 2010
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: April 1, 2010
• Last Updated: August 4, 2010

Record last verified: 2010-04

Locations

DE (1)