- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01759199
The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)? (STEPPER)
November 26, 2025 updated by: University Hospital, Brest
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Morlaix, Brittany, France, 29600
- Hospital of Morlaix
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Brittany Region
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Brest, Brittany Region, France, 29200
- Brest University Hospital
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Morlaix, Brittany Region, France, 29600
- Hospital of Morlaix
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pneumonectomy, Lobectomy less than 6 months
- orthopedic problem
- Balance disorder
- Weight > 110kg
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The six minute Stepper Test
Experimental : The six minute Stepper Test with a Conventional respiratory rehabilitation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of steps to The Six-minute Stepper Test (ST6)
Time Frame: 21 days
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Assess the difference in the number of steps in ST6 before and after pulmonary rehabilitation
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21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: FRANCIS COUTURAUD, MD,PHD, Brest University Hospital Brest,, Brittany, France 29200
- Principal Investigator: CATHERINE LE BER-MOY, DR., Hospital of Morlaix Morlaix, Brittany, France 29600
- Principal Investigator: CHANTAL LOCHON, DR., Hospital of Morlaix Morlaix, Brittany, France 29600
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
December 4, 2012
First Submitted That Met QC Criteria
December 27, 2012
First Posted (Estimated)
January 3, 2013
Study Record Updates
Last Update Posted (Estimated)
December 3, 2025
Last Update Submitted That Met QC Criteria
November 26, 2025
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RB 11-157 STEPPER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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