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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Procedure: pulmonary outpatient rehabilitation

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
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-Minute walk distance	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	General and disease-specific health-related quality of life measured using the Short-Form 36-Questionaire resp. the St. George's-Respiratory Questionaire	Six months
Maximum oxygen uptake	Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.	Six months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Dr. Tibor Schmoller, pulmonary practice Winterhude
• Investigators: Principal Investigator: Andreas Meyer, M.D., Kliniken Mariahilf GmbH, Mönchengladbach, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (Estimate): September 6, 2010

Study Record Updates

• Last Update Posted (Estimate): September 6, 2010
• Last Update Submitted That Met QC Criteria: September 3, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: COPD; pulmonary rehabilitation
• Other Study ID Numbers: AIR-01