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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
History of Changes
  Purpose

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 Intervention
COPD
 Procedure: pulmonary outpatient rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 6-Minute walk distance [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: April 2004
Study Completion Date: February 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195402

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

No publications provided

Responsible Party: Dr. Andreas Meyer, Kliniken Mariahilf GmbH, Department of Pneumology, Mönchengladbach, Germany
ClinicalTrials.gov Identifier: NCT01195402     History of Changes
Other Study ID Numbers: AIR-01
Study First Received: September 2, 2010
Last Updated: September 3, 2010
Health Authority: Germany: Ministry of Health

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
COPD
pulmonary rehabilitation

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

ClinicalTrials.gov processed this record on May 21, 2013