Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

— AIR  

Official title:

Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195402
• Other study ID #: AIR-01
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: September 3, 2010
• Start date: April 2004
• Est. completion date: February 2006

Study information

• Verified date: September 2010
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Dr. Tibor Schmoller, pulmonary practice Winterhude

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Minute walk distance		Six months	No
Secondary	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	No
Secondary	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	No