Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) (AIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01195402
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : September 6, 2010
Dr. Tibor Schmoller, pulmonary practice Winterhude
Information provided by:
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
COPD Procedure: pulmonary outpatient rehabilitation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD
Study Start Date : April 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 6-Minute walk distance [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Six months ]
    General and disease-specific health-related quality of life measured using the Short-Form 36-Questionaire resp. the St. George's-Respiratory Questionaire

  2. Maximum oxygen uptake [ Time Frame: Six months ]
    Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01195402

University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Dr. Tibor Schmoller, pulmonary practice Winterhude
Principal Investigator: Andreas Meyer, M.D. Kliniken Mariahilf GmbH, Mönchengladbach, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Andreas Meyer, Kliniken Mariahilf GmbH, Department of Pneumology, Mönchengladbach, Germany Identifier: NCT01195402     History of Changes
Other Study ID Numbers: AIR-01
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
pulmonary rehabilitation

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases