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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
respiratory biofeedback
Sponsored by
University Hospital, Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring clinically stable, COPD (GOLD-classification I-IV), COPD, breathing retraining, pulmonary rehabilitation, cardiac autonomic function, quality of life, exercise capacity, pulmonary function

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ruhrlandklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

No Intervention

Arm Label

pulmonary rehabilitation, no breathing retraining

breathing retraining

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

cardiopulmonary exercise capacity
6-minute walking distance, 6MWD

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2010
Last Updated
August 3, 2010
Sponsor
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01175265
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Essen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulmonary rehabilitation, no breathing retraining
Arm Type
No Intervention
Arm Description
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).
Arm Title
breathing retraining
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
respiratory biofeedback
Intervention Description
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 Outcome Measure Information:
Title
cardiopulmonary exercise capacity
Description
6-minute walking distance, 6MWD
Secondary Outcome Measure Information:
Title
pulmonary function
Description
pulmonary function (FEV1)
Title
quality of life
Description
health related quality of life (chronic respiratory questionnaire, CRQ)
Title
autonomic function
Description
cardiac autonomic function (rMSSD)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Teschler, Prof. Dr. dipl Ing
Organizational Affiliation
Ruhlrandklink Essen
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Ruhrlandklinik
City
Essen
State/Province
Nordrheinwestfalen
ZIP/Postal Code
45239
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21474911
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.
Results Reference
derived

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

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