Chronic Obstructive Pulmonary DiseaseSTEPPERNCT01759199
The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?
A study testing Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Brest at 3 sites in France.
Trial summary
The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker of exercise tolerance evolution during a pulmonary rehabilitation program in people with all stages of severity of Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2012to Aug 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with COPD wtih all stages of severity
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course
Who cannot join
- Pneumonectomy, Lobectomy less than 6 months
- orthopedic problem
- Balance disorder
- Weight > 110kg
Trial locations and contacts
3 sites in 1 country.
France3 sites
Brest University Hospital
Brest, Brittany Region, 29200
Hospital of Morlaix
Morlaix, Brittany Region, 29600
Hospital of Morlaix
Morlaix, Brittany, 29600
About this study
Official title: The Six-minute Stepper Test : Marker of Exercise Tolerance's Evolution During Pulmonary Rehabilitation in Patients With COPD ?
The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker of exercise tolerance evolution during a pulmonary rehabilitation program in people with all stages of severity of Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
Currently, the reference test in assessing functional capacity in COPD patients during pulmonary rehabilitation is the six-Minute Walking Test (6MWT). However, the realization of the 6MWT requires a 30m-long corridor, according to the American Thoracic Society Guidelines. Lack of sufficient space can prevent the realization of 6MWT, especially for private practitioner pulmonologists, and also in hospitals. The six-minute stepper test (ST6) which can be performed in a normal room, should be an interesting alternative.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test
- Keywords
- COPD, ST6: The six minute Stepper Test, Conventional respiratory rehabilitation, 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 rehabilitation assessed with six-minute walk test and six-minute stepper testProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| The six minute Stepper Test | Experimental | Experimental : The six minute Stepper Test with a Conventional respiratory rehabilitation Receives: Procedure: Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of steps to The Six-minute Stepper Test (ST6)
Assess the difference in the number of steps in ST6 before and after pulmonary rehabilitation
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
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.
- More trials run by University Hospital, BrestThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- FRANCIS COUTURAUD, MD,PHD, Principal investigator, Brest University Hospital Brest,, Brittany, France 29200CATHERINE LE BER-MOY, DR., Principal investigator, Hospital of Morlaix Morlaix, Brittany, France 29600CHANTAL LOCHON, DR., Principal investigator, Hospital of Morlaix Morlaix, Brittany, France 29600
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759199
- Sponsor's protocol ID
- RB 11-157 STEPPER
- Acronym
- STEPPER
- Status last verified
- Nov 2013
- First submitted
- 4 Dec 2012
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Pichon R, Couturaud F, Mialon P, Le Ber-Moy C, Peran L, Lochon C, Nowak E, Beaumont M. Responsiveness and Minimally Important Difference of the 6-Minute Stepper Test in Patients with Chronic Obstructive Pulmonary Disease. Respiration. 2016;91(5):367-73. doi: 10.1159/000446517. Epub 2016 May 25.
PubMed 27216848
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Six-minute Stepper Test : Marker of Exercise Tolerance's Evolution During Pulmonary Rehabilitation in Patients With COPD ?
- ClinicalTrials.gov ID
- NCT01759199
- Acronym / sponsor ID
- STEPPER / RB 11-157 STEPPER
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, ST6: The six minute Stepper Test, Conventional respiratory rehabilitation, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Jan 2013 (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 this study is to show if the six-minute stepper test (ST6) is a sensible marker of exercise tolerance evolution during a pulmonary rehabilitation program in people with all stages of severity of Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
Currently, the reference test in assessing functional capacity in COPD patients during pulmonary rehabilitation is the six-Minute Walking Test (6MWT). However, the realization of the 6MWT requires a 30m-long corridor, according to the American Thoracic Society Guidelines. Lack of sufficient space can prevent the realization of 6MWT, especially for private practitioner pulmonologists, and also in hospitals. The six-minute stepper test (ST6) which can be performed in a normal room, should be an interesting alternative.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The six minute Stepper Test | Experimental | Procedure: Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper testExperimental : The six minute Stepper Test with a Conventional respiratory rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with COPD wtih all stages of severity
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course
Key exclusion criteria (4 listed)
- Pneumonectomy, Lobectomy less than 6 months
- orthopedic problem
- Balance disorder
- Weight > 110kg
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 rehabilitation assessed with six-minute walk test and six-minute stepper test | Procedure or surgery | The six minute Stepper Test |
Primary outcome
The number of steps to The Six-minute Stepper Test (ST6)
Time frame: 21 days
Assess the difference in the number of steps in ST6 before and after pulmonary rehabilitation
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 3 Dec 2025.
- Results publication: PubMed 27216848Pichon R, Couturaud F, Mialon P, Le Ber-Moy C, Peran L, Lochon C, Nowak E, Beaumont M. Responsiveness and Minimally Important Difference of the 6-Minute Stepper Test in Patients with Chronic Obstructive Pulmonary Disease. Respiration. 2016;91(5):367-73. doi: 10.1159/000446517. Epub 2016 May 25.
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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.
FRANCIS COUTURAUD, MD,PHD principal investigator
Brest University Hospital Brest,, Brittany, France 29200
CATHERINE LE BER-MOY, DR. principal investigator
Hospital of Morlaix Morlaix, Brittany, France 29600
CHANTAL LOCHON, DR. principal investigator
Hospital of Morlaix Morlaix, Brittany, France 29600
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Brest 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 2 inclusion and 4 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 3 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?
The number of steps to The Six-minute Stepper Test (ST6) (time frame: 21 days). 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 NCT01759199, 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 3 Dec 2025.