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Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)

Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01195402
Acronym
AIR
Enrollment
100
Registered
2010-09-06
Start date
2004-04-30
Completion date
2006-02-28
Last updated
2010-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, pulmonary rehabilitation

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.

Interventions

PROCEDUREpulmonary 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.

Sponsors

Dr. Tibor Schmoller, pulmonary practice Winterhude
CollaboratorUNKNOWN
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
6-Minute walk distanceSix months

Secondary

MeasureTime frameDescription
Maximum oxygen uptakeSix monthsMaximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.
Quality of lifeSix monthsGeneral and disease-specific health-related quality of life measured using the Short-Form 36-Questionaire resp. the St. George's-Respiratory Questionaire

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026