Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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This randomised-controlled study is undertaken to investigate the effects of a long term low intensity outpatient training program on physical fitness and quality of life in moderate to severe COPD patients.

Detailed Description
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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.

Official Title
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Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD

Conditions
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COPD

Intervention / Treatment
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* Procedure: pulmonary outpatient rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD GOLD stage II-IV smoking history of >20 pack years adequate pharmacological therapy written informed consent Exclusion Criteria: respiratory insufficiency, defined as PaO2<55 mm Hg and/or PaCO2>50 mm Hg breathing room air manifest cardiac insufficiency uncontrolled arterial hypertension malignant disease symptomatic coronary heart disease resp. pathological cycle ergometry results limited physical capabilities caused by musculoskeletal disorders unwillingness to return for follow-up previous or ongoing participation in exercise training programs unability to attend at least 75% of sessions

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Subjects do not receive any kind of active intervention. | |
| Active Comparator: pulmonary outpatient rehabilitation<br>Subjects participate in an outpatient pulmonary rehabilitation program | Procedure: pulmonary outpatient rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute walk distance |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | General and disease-specific health-related quality of life measured using the Short-Form 36-Questionaire resp. the St. George's-Respiratory Questionaire | Six months | 
| Maximum oxygen uptake | Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, pulmonary rehabilitation