Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

• Conditions: COPD
• Interventions: Procedure: pulmonary outpatient rehabilitation

• Registration Number: NCT01195402
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-04
• Primary Completion: 2005-12
• Study Completion: 2006-02
• Status Verified: 2010-09
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-03
• Last Update Submitted: 2010-09-03
• Study First Posted: 2010-09-06
• Last Update Posted: 2010-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulmonary outpatient rehabilitation	pulmonary outpatient rehabilitation	Subjects participate in an outpatient pulmonary rehabilitation program

Primary Outcome Measures

Name	Time	Method
6-Minute walk distance	Six months

Secondary Outcome Measures

Name	Time	Method
Quality of life	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
Maximum oxygen uptake	Six months	Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany