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Completed

NCT Number: NCT01195402

Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary outpatient rehabilitation

Procedure

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.

Primary outcomes

  1. 6-Minute walk distance

    Time frame: Six months

Secondary outcomes

  1. Quality of life

    Time frame: 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

  2. Maximum oxygen uptake

    Time frame: Six months

    Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Dr. Tibor Schmoller, pulmonary practice Winterhude

Registry information

Official study title

Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD

Acronym: AIR

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Sep 6, 2010
Registry last updated
Sep 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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