Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)
AIR
Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 2, 2010
CompletedFirst Posted
Study publicly available on registry
September 6, 2010
CompletedSeptember 6, 2010
September 1, 2010
1.7 years
September 2, 2010
September 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-Minute walk distance
Six months
Secondary Outcomes (2)
Quality of life
Six months
Maximum oxygen uptake
Six months
Study Arms (2)
Control
NO INTERVENTIONSubjects do not receive any kind of active intervention.
pulmonary outpatient rehabilitation
ACTIVE COMPARATORSubjects participate in an outpatient pulmonary rehabilitation program
Interventions
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.
Eligibility Criteria
You may qualify if:
- COPD GOLD stage II-IV
- smoking history of \>20 pack years
- adequate pharmacological therapy
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Related Publications (1)
Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86.
PMID: 23017153DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Meyer, M.D.
Kliniken Mariahilf GmbH, Mönchengladbach, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2010
First Posted
September 6, 2010
Study Start
April 1, 2004
Primary Completion
December 1, 2005
Study Completion
February 1, 2006
Last Updated
September 6, 2010
Record last verified: 2010-09