Chronic Obstructive Pulmonary DiseasePH-6MSTNCT04008615
Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by ADIR Association at 3 sites in France.
Trial summary
Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment. Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, 6-minute Stepper Test
- What is being tested?
- 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).
- How many people
- 65 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Aug 2019to 30 Jun 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
Who may be able to join
- Age > 18 ans ;
- Chronicle obstructive pulmonary disease stage I/IV ;
- Weight ≤ 90kg ;
- Eligible for pulmonary rehabilitation.
Who cannot join
- Require during exercise oxygen ;
- Pregnant woman or likely to be ;
- Patient under guardianship ;
- Contraindication to cardiopulmonary exercise testing ;
- Patient medically treated with heart rate modulator (excluding oral B2-agonist) ;
- Patient treated with pacemaker or defibrillator ;
- History of lower limb impairment (i.e. peripheral artery disease, orthopedic disorder etc.).
Trial locations and contacts
3 sites in 1 country.
France3 sites
ADIR Association
Bois-Guillaume
Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil
Elbeuf
Groupe Hospitalier du Havre
Le Havre
About this study
Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.
Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.
Read more
In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.
The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.
The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored.
Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed.
Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise.
Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer.
The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.
Read the detailed description
Experimental design:
This study is a pre-specified ancillary study to two other studies (with exactly the same design but a different population) aimed to assess the usability of the six-minute stepper test to prescribe endurance training in patients with mild to moderate (NCT02842463) and severe to very severe (NCT04004689) chronicle obstructive pulmonary disease respectively.
Patients already participating in one of these studies will be approached and offered to participate in an additional testing session (on a different day) using exactly the same procedure but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry).
Data from these additional two six-minute stepper tests will be compared with those obtained from the previously performed incremental cardiopulmonary exercise testing.
According to the American Thoracic Society and American College of Chest Physicians statement on cardiopulmonary exercise testing, maximality will be considered if either one or more of the following criteria occured:
- The patient achieves predicted peak oxygen uptake and/or a plateau is observed.
- Predicted maximal heart rate is achieved (>90%)
- There is evidence of ventilatory limitation (breathing reserve <11liters or < 15%)
- Respiratory exchange ratio > 1.15
- Patient exhaustion/Borg Scale rating of 9-10 on a 0-to-10 scale.
Phase II oxygen consumption kinetics will be modelized by averaging the breath by breath measurement over consecutive periods of 5s for using the following monoexponential equation :
VO2 (τ) = VO2rest + VO2ss - VO2rest))*(1-e-t/τ). with " VO2rest " representing the baseline level of VO2 at rest, " VO2ss " representing the steady state of VO2 during exertion and τ (time constant) representing the time course of the monoexponential VO2 curve. The amplitude of the VO2 (VO2span) corresponds to the difference between VO2ss and VO2rest.
A curve by curve analysis will be performed across participants and parameters (time constant, span and steady state oxygen consumption) will be compared according to the stage of severity.
- Being tested
- 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).
- 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.
2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).Other
For the 6-minute stepper test, please refer to NCT02842463 and NCT04004689. Gaz exchange analyzer will be calibrate before every test. Data will be recorded breath by breath.
Heart rate will be monitored using a 12-lead electrocardiogram. Transcutaneous oxygen saturation will be assessed using a pulse oxymetry system at the earlobe.
| Study group | Role | What they receive |
|---|---|---|
| Prospective observational cohort | Every patient referred to pulmonary rehabilitation program will be eligible. They will perform cardiopulmonary exercise testing prior to join rehabilitation program.
During the first session of pulmonary rehabilitation, they will perform 2 6-minute stepper test with a rest of 20 minutes minimum between each test.
For the purpose of this study, patients will be offered to participate in an additional exercise session in which they will repeat the same procedure (two 6-minute stepper test) but but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry). Receives: Other: 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption using indirect calorimetry
The tests will be performed using a face mask, a pneumotachograph and a gaz analyzer.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Secondary outcomes (13)
Steps during 6-minute stepper test using stepper device.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Carbon dioxide production using indirect calorimetry
The tests will be performed using a face mask, a pneumotachograph and a gaz analyzer.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Heart rate using a 12-lead electrocardiogram
Heart rate wil be continuously monitored throughout the tests.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Transcutaneous oxygen saturation using a pulse oxymetry system
Transcutaneous oxygen saturation will be continuously monitored throughout the tests at the earlobe.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Tidal volume using a pneumotachograph
The outcome will be continuously monitored throughout the tests.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Respiratory rate using a pneumotachograph
The outcome will be continuously monitored throughout the tests.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Minute ventilation using a pneumotachograph
The outcome will be continuously monitored throughout the tests.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Respiratory exchange ratio using indirect calorimetry
The outcome will be continuously monitored throughout the tests.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Oxygen equivalent using indirect calorimetry
The outcome will be continuously monitored throughout the tests and calculated as the ratio between minute ventilation to oxygen consumption
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Carbon dioxide equivalent using indirect calorimetry
The outcome will be continuously monitored throughout the tests and calculated as the ratio between minute ventilation to carbon dioxide production
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Ratio between dead space volume to tidal volume using a pneumotachograph and indirect calorimetry
The outcome will be continuously monitored throughout the tests.
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Dyspnea using the Borg scale
Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness)
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Lower limb fatigue using the Borg scale
Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness)
Measured: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Aug 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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 Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Debeaumont, MD, Principal investigator, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, FranceCatherine Tardif, MD, Study chair, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, FranceAntoine Cuvelier, Prof, PhD, Study chair, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.Tristan Bonnevie, MsC, Study chair, ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, FranceFrancis-Edouard Gravier, PT, Study chair, ADIR Association, Bois-Guillaume, FranceCatherine Viacroze, MD, Study chair, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, FranceJean-François Muir, Prof, PhD, Study chair, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, FranceBouchra Lamia, Prof, PhD, Study chair, UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008615
- Sponsor's protocol ID
- PH-6MST
- Acronym
- PH-6MST
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2019
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hinfray A, Vanheule A, Kerfourn A, Cuvelier A, Viacroze C, Debeaumont D, Gravier FE, Bonnevie T. Peak cardiorespiratory and metabolic responses during the six-minute stepper test in people with COPD: A pre-planned cross-sectional ancillary study. Pulmonology. 2026 Dec;32(1):2683324. doi: 10.1080/25310429.2026.2683324. Epub 2026 Jun 4.
PubMed 42240854
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04008615
- Acronym / sponsor ID
- PH-6MST / PH-6MST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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.
Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.
Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.
In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.
The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.
The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored.
Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed.
Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise.
Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer.
The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.
Detailed description
Experimental design:
This study is a pre-specified ancillary study to two other studies (with exactly the same design but a different population) aimed to assess the usability of the six-minute stepper test to prescribe endurance training in patients with mild to moderate (NCT02842463) and severe to very severe (NCT04004689) chronicle obstructive pulmonary disease respectively.
Patients already participating in one of these studies will be approached and offered to participate in an additional testing session (on a different day) using exactly the same procedure but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry).
Data from these additional two six-minute stepper tests will be compared with those obtained from the previously performed incremental cardiopulmonary exercise testing.
According to the American Thoracic Society and American College of Chest Physicians statement on cardiopulmonary exercise testing, maximality will be considered if either one or more of the following criteria occured:
- The patient achieves predicted peak oxygen uptake and/or a plateau is observed.
- Predicted maximal heart rate is achieved (>90%)
- There is evidence of ventilatory limitation (breathing reserve <11liters or < 15%)
- Respiratory exchange ratio > 1.15
- Patient exhaustion/Borg Scale rating of 9-10 on a 0-to-10 scale.
Phase II oxygen consumption kinetics will be modelized by averaging the breath by breath measurement over consecutive periods of 5s for using the following monoexponential equation :
VO2 (τ) = VO2rest + VO2ss - VO2rest))*(1-e-t/τ). with " VO2rest " representing the baseline level of VO2 at rest, " VO2ss " representing the steady state of VO2 during exertion and τ (time constant) representing the time course of the monoexponential VO2 curve. The amplitude of the VO2 (VO2span) corresponds to the difference between VO2ss and VO2rest.
A curve by curve analysis will be performed across participants and parameters (time constant, span and steady state oxygen consumption) will be compared according to the stage of severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective observational cohort | – | Other: 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).Every patient referred to pulmonary rehabilitation program will be eligible. They will perform cardiopulmonary exercise testing prior to join rehabilitation program. During the first session of pulmonary rehabilitation, they will perform 2 6-minute stepper test with a rest of 20 minutes minimum between each test. For the purpose of this study, patients will be offered to participate in an additional exercise session in which they will repeat the same procedure (two 6-minute stepper test) but but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
Key inclusion criteria (4 listed)
- Age > 18 ans ;
- Chronicle obstructive pulmonary disease stage I/IV ;
- Weight ≤ 90kg ;
- Eligible for pulmonary rehabilitation.
Key exclusion criteria (7 listed)
- Require during exercise oxygen ;
- Pregnant woman or likely to be ;
- Patient under guardianship ;
- Contraindication to cardiopulmonary exercise testing ;
- Patient medically treated with heart rate modulator (excluding oral B2-agonist) ;
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 |
|---|---|---|
| 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).For the 6-minute stepper test, please refer to NCT02842463 and NCT04004689. Gaz exchange analyzer will be calibrate before every test. Data will be recorded breath by breath. Heart rate will be monitored using a 12-lead electrocardiogram. Transcutaneous oxygen saturation will be assessed using a pulse oxymetry system at the earlobe. | Other | Prospective observational cohort |
Primary outcome
Oxygen consumption using indirect calorimetry
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
The tests will be performed using a face mask, a pneumotachograph and a gaz analyzer.
13 secondary outcomes
Steps during 6-minute stepper test using stepper device.
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Carbon dioxide production using indirect calorimetry
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Heart rate using a 12-lead electrocardiogram
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Transcutaneous oxygen saturation using a pulse oxymetry system
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Tidal volume using a pneumotachograph
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Respiratory rate using a pneumotachograph
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Minute ventilation using a pneumotachograph
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Respiratory exchange ratio using indirect calorimetry
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Oxygen equivalent using indirect calorimetry
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Carbon dioxide equivalent using indirect calorimetry
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Ratio between dead space volume to tidal volume using a pneumotachograph and indirect calorimetry
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Dyspnea using the Borg scale
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Lower limb fatigue using the Borg scale
Time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
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 9 Dec 2025.
- Derived from this study: PubMed 42240854Hinfray A, Vanheule A, Kerfourn A, Cuvelier A, Viacroze C, Debeaumont D, Gravier FE, Bonnevie T. Peak cardiorespiratory and metabolic responses during the six-minute stepper test in people with COPD: A pre-planned cross-sectional ancillary study. Pulmonology. 2026 Dec;32(1):2683324. doi: 10.1080/25310429.2026.2683324. Epub 2026 Jun 4.
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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.
David Debeaumont, MD principal investigator
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Catherine Tardif, MD study chair
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Antoine Cuvelier, Prof, PhD study chair
CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by ADIR Association at 3 sites 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 4 inclusion and 7 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 9 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 3 sites 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?
Oxygen consumption using indirect calorimetry (time frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.). 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 NCT04008615, 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 9 Dec 2025.