Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) (AIR)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD|
- 6-Minute walk distance [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Six months ] [ Designated as safety issue: No ]General and disease-specific health-related quality of life measured using the Short-Form 36-Questionaire resp. the St. George's-Respiratory Questionaire
- Maximum oxygen uptake [ Time Frame: Six months ] [ Designated as safety issue: No ]Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.
|Study Start Date:||April 2004|
|Study Completion Date:||February 2006|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
No Intervention: Control
Subjects do not receive any kind of active intervention.
Active Comparator: pulmonary outpatient rehabilitation
Subjects participate in an outpatient pulmonary rehabilitation program
Procedure: pulmonary outpatient rehabilitation
Subjects take part in once weekly training sessions of 60 min duration. Sessions take place in local physiotherapist practice and involve simple training devices (chairs, elastic bands, balls). In addition, subjects take part in a structured and validated educational program concerning COPD (COBRA) of 8 h duration. They are offered counselling regarding nutrition (2 h), psycho-social (2 h) and social (2 h) aspects.
Broad evidence exists on the beneficial effects of pulmonary rehabilitation on exercise capabilities and quality of life in COPD patients. Clinically relevant effects have been achieved by training programs of differing design regarding setting (inpatient vs. outpatient vs. home-based), duration (short-term vs. long-term) and intensity (high vs. low intensity).
While there is sufficient evidence to propose pulmonary rehabilitation its use is generally low in clinical practice. One reason may be that it is unlikely that costly programs are offered to a significant proportion of eligible patients. The ideal training program will therefore at the same time accomplish the greatest improvements regarding physical capabilities and quality of life and sustain them for the longest period at the lowest cost.
The purpose of the present study is to evaluate whether a continuous, low-intensity, low-cost, physiotherapist-led outpatient pulmonary rehabilitation program is a able to achieve significant long-term improvements of exercise tolerance and quality of life in moderate to severe COPD patients at a lower cost level than previously published programs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195402
|University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Andreas Meyer, M.D.||Kliniken Mariahilf GmbH, Mönchengladbach, Germany|