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

This study has been completed.
Sponsor:
Collaborator:
Dr. Tibor Schmoller, pulmonary practice Winterhude
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01195402
First received: September 2, 2010
Last updated: September 3, 2010
Last verified: September 2010

September 2, 2010
September 3, 2010
April 2004
December 2005   (final data collection date for primary outcome measure)
6-Minute walk distance [ Time Frame: Six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01195402 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: Six months ] [ Designated as safety issue: No ]
    General and disease-specific health-related quality of life measured using the Short-Form 36-Questionaire resp. the St. George's-Respiratory Questionaire
  • Maximum oxygen uptake [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.
Same as current
Not Provided
Not Provided
 
Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)
Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
COPD
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.
  • 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
    Intervention: Procedure: pulmonary outpatient rehabilitation
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;13:86. doi: 10.1186/1465-9921-13-86.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2006
December 2005   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01195402
AIR-01
No
Dr. Andreas Meyer, Kliniken Mariahilf GmbH, Department of Pneumology, Mönchengladbach, Germany
Universitätsklinikum Hamburg-Eppendorf
Dr. Tibor Schmoller, pulmonary practice Winterhude
Principal Investigator: Andreas Meyer, M.D. Kliniken Mariahilf GmbH, Mönchengladbach, Germany
Universitätsklinikum Hamburg-Eppendorf
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP