Clinical trial NCT01195402: Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
pulmonary rehabilitation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Dr. Tibor Schmoller, pulmonary practice Winterhude
First posted: 2010-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6-Minute walk distance
timeFrame: Six months
Secondary outcomes:
measure: Quality of life
timeFrame: Six months
measure: Maximum oxygen uptake
timeFrame: Six months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Kliniken Mariahilf GmbH, Mönchengladbach, Germany
name: Andreas Meyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.