Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) (AIR)
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| First Received Date ICMJE | September 2, 2010 | ||||
| Last Updated Date | September 3, 2010 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
6-Minute walk distance [ Time Frame: Six months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01195402 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Official Title ICMJE | Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | COPD | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01195402 | ||||
| Other Study ID Numbers ICMJE | AIR-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Andreas Meyer, Kliniken Mariahilf GmbH, Department of Pneumology, Mönchengladbach, Germany | ||||
| Study Sponsor ICMJE | Universitätsklinikum Hamburg-Eppendorf | ||||
| Collaborators ICMJE | Dr. Tibor Schmoller, pulmonary practice Winterhude | ||||
| Investigators ICMJE |
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| Information Provided By | Universitätsklinikum Hamburg-Eppendorf | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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