Clinical trial NCT01175265: Effects of Breathing Retraining in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effects of Breathing Retraining on Pulmonary Function, Exercise Capacity, Quality of Life and Cardiac Autonomic Function in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: cardiopulmonary exercise capacity
Secondary outcomes:
measure: pulmonary function
measure: quality of life
measure: autonomic function
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Ruhrlandklinik
state: Nordrheinwestfalen
Study officials:
affiliation: Ruhlrandklink Essen
name: Helmut Teschler, Prof. Dr. dipl Ing
role: STUDY_DIRECTOR
References:
citation: 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.