Chronic Obstructive Pulmonary Disease6STaRNCT02842463

6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Chronicle Obstructive Pulmonary Disease

An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by ADIR Association at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine, if it exists, a relation between plateau heart rate from the last 3 minutes of the 6-minute stepper test and heart rate from first ventilatory threshold from cardiopulmonary exercise testing in order to individualise pulmonary rehabilitation in patients with mild to moderate… 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 a rest of 20min between each test.
How many people: 105 participants
Where: 4 sitesFrance
Study dates: Jul 2016to Dec 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/II (FEV1 ≥ 50%) ;
Chronicle obstructive pulmonary disease stage III/IV (FEV1 < 50%) from may 2019 (ethical approvement granted)
Weight ≤ 90kg ;
Eligible for pulmonary rehabilitation.

Who cannot join

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

4 sites in 1 country.

France4 sites

ADIR Association
Bois-Guillaume
Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil
Elbeuf
Groupe Hospitalier du Havre
Le Havre
Centre Hospitalier de Morlaix
Morlaix

Other trials in France

About this study

Official title: Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Mild to Moderate Chronicle Obstructive Pulmonary Disease

Conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, 6-minute Stepper Test
Being tested: 2 times : 6-minute stepper test 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 a rest of 20min between each test.Other

Study groups in NCT02842463
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. Receives: Other: 2 times : 6-minute stepper test 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.

Relation between plateau heart rate (bpm) from the first and last 3 minutes of the 6-minute stepper test and heart rate (bpm) from first ventilatory threshold from cardiopulmonary exercise testing.
Outcome (heart rate) during different tests will be continuously recorded. Relation will be adjusted for age and step count.
Measured: Heart rate (bpm) will be assessed during cardiopulmonary exercise testing with electrocardiogram. During the 2 6-minute stepper test, heart will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.

Secondary outcomes (3)

Relation between minimal SpO2 (%)from the 6-minute stepper test and SpO2 (%) from first ventilatory threshold from cardiopulmonary exercise testing.
Outcome (SpO2 (%)) during different tests will be continuously recorded. Relation will be adjusted for age en step count.
Measured: SpO2 will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.
Blood pressure (mmHg) before and after every 6-minute stepper test using electrical blood pressure device.
Measured: The outcome will be assessed before and after every 6-minute stepper test. The 2 6-minute stepper test will be carried out the same day (minimum 20 minute of rest between each test) for a total time frame of 1 day.
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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Dec 2023

First posted25 Jul 2016 (estimated)
Study startJul 2016
Primary completionDec 2023
Study completionDec 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: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02842463
Sponsor's protocol ID: 6STaR
Acronym: 6STaR
Status last verified: Mar 2024
First submitted: 19 Jul 2016
Last updated: 21 Mar 2024
Results posted: No

Publications

Bonnevie T, Clet A, Beaumont M, Smondack P, Combret Y, Medrinal C, Prieur G, Boujibar F, Muir JF, Cuvelier A, Grosbois JM, Debeaumont D, Artaud-Macari E, Gravier FE. Estimating endurance training intensity prescription from the 6-minute stepper test in people with chronic obstructive pulmonary disease - a multicenter cross-sectional study with external validation. Pulmonology. 2025 Dec 31;31(1):2486875. doi: 10.1080/25310429.2025.2486875. Epub 2025 Apr 11.
PubMed 40211884

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Mild to Moderate Chronicle Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT02842463
Acronym / sponsor ID: 6STaR / 6STaR
Conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, 6-minute Stepper Test
Study type: Observational
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: ADIR AssociationUniversity, hospital or other
Study start: Jul 2016 (actual)
Primary completion: Dec 2023 (actual)
Study completion: Dec 2023 (actual)
First posted: 25 Jul 2016 (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.

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 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.

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 (5 listed)

Age > 18 ans ;
Chronicle obstructive pulmonary disease stage I/II (FEV1 ≥ 50%) ;
Chronicle obstructive pulmonary disease stage III/IV (FEV1 < 50%) from may 2019 (ethical approvement granted)
Weight ≤ 90kg ;
Eligible for pulmonary rehabilitation.

Key exclusion criteria (6 listed)

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 ;

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 a rest of 20min between each test.	Other	Prospective observational cohort

Primary outcome

Relation between plateau heart rate (bpm) from the first and last 3 minutes of the 6-minute stepper test and heart rate (bpm) from first ventilatory threshold from cardiopulmonary exercise testing.
Time frame: Heart rate (bpm) will be assessed during cardiopulmonary exercise testing with electrocardiogram. During the 2 6-minute stepper test, heart will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.
Outcome (heart rate) during different tests will be continuously recorded. Relation will be adjusted for age and step count.

3 secondary outcomes

Relation between minimal SpO2 (%)from the 6-minute stepper test and SpO2 (%) from first ventilatory threshold from cardiopulmonary exercise testing.
Time frame: SpO2 will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.
Blood pressure (mmHg) before and after every 6-minute stepper test using electrical blood pressure device.
Time frame: The outcome will be assessed before and after every 6-minute stepper test. The 2 6-minute stepper test will be carried out the same day (minimum 20 minute of rest between each test) for a total time frame of 1 day.
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.

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 21 Mar 2024.
Derived from this study: PubMed 40211884Bonnevie T, Clet A, Beaumont M, Smondack P, Combret Y, Medrinal C, Prieur G, Boujibar F, Muir JF, Cuvelier A, Grosbois JM, Debeaumont D, Artaud-Macari E, Gravier FE. Estimating endurance training intensity prescription from the 6-minute stepper test in people with chronic obstructive pulmonary disease - a multicenter cross-sectional study with external validation. Pulmonology. 2025 Dec 31;31(1):2486875. doi: 10.1080/25310429.2025.2486875. Epub 2025 Apr 11.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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.

4 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 4 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 5 inclusion and 6 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Relation between plateau heart rate (bpm) from the first and last 3 minutes of the 6-minute stepper test and heart rate (bpm) from first ventilatory threshold from cardiopulmonary exercise testing. (time frame: Heart rate (bpm) will be assessed during cardiopulmonary exercise testing with electrocardiogram. During the 2 6-minute stepper test, heart will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.). 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 NCT02842463, 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 21 Mar 2024.