Pulmonary Disease, Chronic ObstructiveNCT00295113
Interest of a 30 Minutes' Intermittent Work Exercise Test in Patients With Chronic Obstructive Pulmonary Disease: Cardiac and Pulmonary Functions
A study testing EFR in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of the study is to observe the ventilatory and cardiac function (included the pulmonary arterial pressure) during an intermittent work exercise test with high density work load. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- EFR
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2001to Jun 2003
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients (male and female) with moderate obstruction (FEV1/CV<60%)
Who cannot join
- acute respiratory disease
- any type of cardiac disease
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles
Strasbourg, 67091
About this study
The aim of the study is to observe the ventilatory and cardiac function (included the pulmonary arterial pressure) during an intermittent work exercise test with high density work load.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- EFR
- Keywords
- Pulmonary arterial pressure, COPD, Cardiac output, pulmonary and cardiac functions, pulmonary arterial pressure measurements
- 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.
EFRProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The pulmonary arterial pressure does not increase dramatically during the 30 minutes exercise test, but decreases significantly after the first 5 minutes of exercise.
Secondary outcomes (1)
The cardiac output is stable after the first 5 minutes of exercise, despite the high intensity work loads every 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startNov 2001
- Primary completionJun 2003
- Study completionJun 2003
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 Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruddy RICHARD, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'ExerciceEvelyne LONSDORFER-WOLF, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295113
- Sponsor's protocol ID
- 2398
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2005
- Last updated
- 22 Dec 2025
- Results posted
- No
Publications
Bougault V, Lonsdorfer-Wolf E, Charloux A, Richard R, Geny B, Oswald-Mammosser M. Does thoracic bioimpedance accurately determine cardiac output in COPD patients during maximal or intermittent exercise? Chest. 2005 Apr;127(4):1122-31. doi: 10.1378/chest.127.4.1122.
PubMed 15821184
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a 30 Minutes' Intermittent Work Exercise Test in Patients With Chronic Obstructive Pulmonary Disease: Cardiac and Pulmonary Functions
- ClinicalTrials.gov ID
- NCT00295113
- Acronym / sponsor ID
- 2398
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary arterial pressure, COPD, Cardiac output, pulmonary and cardiac functions, pulmonary arterial pressure measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2001 (actual)
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 22 Feb 2006 (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.
The aim of the study is to observe the ventilatory and cardiac function (included the pulmonary arterial pressure) during an intermittent work exercise test with high density work load.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients (male and female) with moderate obstruction (FEV1/CV<60%)
Key exclusion criteria (2 listed)
- acute respiratory disease
- any type of cardiac disease
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 |
|---|---|---|
| EFR | Procedure or surgery | – |
Primary outcome
The pulmonary arterial pressure does not increase dramatically during the 30 minutes exercise test, but decreases significantly after the first 5 minutes of exercise.
1 secondary outcome
The cardiac output is stable after the first 5 minutes of exercise, despite the high intensity work loads every 5 minutes.
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 22 Dec 2025.
- Results publication: PubMed 15821184Bougault V, Lonsdorfer-Wolf E, Charloux A, Richard R, Geny B, Oswald-Mammosser M. Does thoracic bioimpedance accurately determine cardiac output in COPD patients during maximal or intermittent exercise? Chest. 2005 Apr;127(4):1122-31. doi: 10.1378/chest.127.4.1122.
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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.
Ruddy RICHARD, MD principal investigator
Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
Evelyne LONSDORFER-WOLF, MD principal investigator
Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFR in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital, Strasbourg, France at 1 site in France.
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 1 inclusion and 2 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 22 Dec 2025. 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 France. 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?
The pulmonary arterial pressure does not increase dramatically during the 30 minutes exercise test, but decreases significantly after the first 5 minutes of exercise.. 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 NCT00295113, 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 22 Dec 2025.