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OpenTrials
Completed

NCT Number: NCT01175265

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

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Ruhrlandklinik

Essen, Nordrheinwestfalen, 45239, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. cardiopulmonary exercise capacity

    6-minute walking distance, 6MWD

Secondary outcomes

  1. pulmonary function

    pulmonary function (FEV1)

  2. quality of life

    health related quality of life (chronic respiratory questionnaire, CRQ)

  3. autonomic function

    cardiac autonomic function (rMSSD)

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 4, 2010
Registry last updated
Aug 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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