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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: COPD

Treatments: Procedure: pulmonary outpatient rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01195402

AIR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control

No Intervention group

Description:

Subjects do not receive any kind of active intervention.

pulmonary outpatient rehabilitation

Active Comparator group

Description:

Subjects participate in an outpatient pulmonary rehabilitation program

Treatment:

Procedure: pulmonary outpatient rehabilitation