COPDAIRNCT01195402
Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)
A study testing pulmonary outpatient rehabilitation in people with COPD, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- pulmonary outpatient rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD GOLD stage II-IV
- smoking history of >20 pack years
- adequate pharmacological therapy
- written informed consent
Who cannot join
- 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
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- unwillingness to return for follow-up
- previous or ongoing participation in exercise training programs
- unability to attend at least 75% of sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe 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.
Read the 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.
- Conditions
- COPD
- Being tested
- pulmonary outpatient rehabilitation
- Keywords
- COPD, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary outpatient rehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects do not receive any kind of active intervention. |
| pulmonary outpatient rehabilitation | Active comparator | Subjects participate in an outpatient pulmonary rehabilitation program Receives: Procedure: pulmonary outpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute walk distance
Measured: Six months
Secondary outcomes (2)
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
Measured: Six months
Maximum oxygen uptake
Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startApr 2004
- Primary completionDec 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Tibor Schmoller, pulmonary practice Winterhude
- Investigators
- Andreas Meyer, M.D., Principal investigator, Kliniken Mariahilf GmbH, Mönchengladbach, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195402
- Sponsor's protocol ID
- AIR-01
- Acronym
- AIR
- Status last verified
- Sep 2010
- First submitted
- 2 Sep 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86.
PubMed 23017153
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT01195402
- Acronym / sponsor ID
- AIR / AIR-01
- Conditions
- COPD
- Keywords
- COPD, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Dr. Tibor Schmoller, pulmonary practice Winterhude
- Study start
- Apr 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects do not receive any kind of active intervention. |
| pulmonary outpatient rehabilitation | Active comparator | Procedure: pulmonary outpatient rehabilitationSubjects participate in an outpatient pulmonary rehabilitation program |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD GOLD stage II-IV
- smoking history of >20 pack years
- adequate pharmacological therapy
- written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary outpatient rehabilitationSubjects 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. | Procedure or surgery | pulmonary outpatient rehabilitation |
Primary outcome
6-Minute walk distance
Time frame: Six months
2 secondary outcomes
Quality of life
Time frame: Six months
Maximum oxygen uptake
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2010.
- Derived from this study: PubMed 23017153Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meyer, M.D. principal investigator
Kliniken Mariahilf GmbH, Mönchengladbach, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary outpatient rehabilitation in people with COPD, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute walk distance (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2010.