Cardiac DiseaseSTEPPERNCT04699136
Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test
A study testing 6 minutes step test (ST6) in people with Cardiac Disease, run by Lille Catholic University at 1 site in France.
Trial summary
The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- 6 minutes step test (ST6)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to 28 Apr 2022
- 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
- Age ≥ 18 years old,
- Patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty),
- Registered in Cardiovascular Rehabilitation at the Mitterie Clinic,
- Number of rehabilitation sessions at least equal to 30,
- Ejection fraction ≥ 45%,
- Signed written consent of the patient,
- Affiliation to a social security scheme.
Who cannot join
- Cardiac decompensation,
- Severe functional limitation,
- Unstable acute coronary syndrome,
- Decompensated heart failure,
- Severe ventricular rhythm disorders,
- Presence of an intracardiac thrombus with high embolic risk,
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- Presence of a medium to large pericardial effusion (effusion of more than 10mm circumferential or 14mm localized on ultrasound),
- Recent history (months prior to inclusion) of thrombophlebitis with or without pulmonary embolism,
- Severe and/or symptomatic left ventricular ejection obstruction,
- Any progressive inflammatory and/or infectious disease,
- Severe pulmonary arterial hypertension,
- Oxygen therapy,
- Musculoskeletal or balance problems that would limit the ability to do any of the following the fiscal year.
- Pregnant or breastfeeding women,
- Incapacity to consent (including persons under guardianship or curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)
The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients
Read the detailed description
The 6-minute stepper test (ST6) is an test used and validated in patients with respiratory disorders (chronic obstructive pulmonary disease) in order to evaluate their tolerance to exercise. It is well tolerated and reproducible in these patients, with the advantage that it can be performed without spatial constraints.
However, this test is not yet used in cardiology. This study proposes to validate the ST6, to evaluate the exercise tolerance of patients suffering from cardiovascular pathologies.
- Conditions
- Cardiac Disease
- Being tested
- 6 minutes step test (ST6)
- Keywords
- Cardiovascular rehabilitation, Stepper test, 6-minute
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minutes step test (ST6)Other
Performing a 6 minutes step test at different intervals and comparing with respect with the 6 minutes walk test and cardiac stress test
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular disease | Experimental | Not described Receives: Other: 6 minutes step test (ST6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal validity of the 6 minutes step test (ST6)
The number of steps taken in 6 minutes with the ST6 will be measured twice on the first day of the cardiovascular rehabilitation and education. The second ST6 will be performed 30 minutes after the first. Internal validity will be studied by calculating the intra-class correlation coefficient (ICC) of the number of steps from the two ST6 carried out and its 95% confidence interval.
Measured: Day 0
External validity of the ST6 with respect to the 6 minutes walk test (WT6)
The external validity with respect to the (6 minutes walk test) WT6 will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the distance travelled in meters from the WT6.
Measured: Day 0
Secondary outcomes (3)
External validity of the ST6 with respect to the cardiac stress test
The external validity with respect to the cardiac stress test will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the cardiac stress test.
Measured: Day 0
External validity of the ST6 with respect to the Oxygen saturation at rest.
The external validity with respect to the Oxygen saturation at rest will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the Oxygen saturation at rest.
Measured: Day 0
External validity of the ST6 with respect to the heart rate at maximum effort
The external validity with respect to the heart rate at maximum effort will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the heart rate.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start13 Jan 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
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 Cardiac 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine SECQ, MD, Principal investigator, Clinique de la Mitterie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699136
- Sponsor's protocol ID
- RC-P0087
- Other IDs
- 2019-A02483-54
- Acronym
- STEPPER
- Status last verified
- Dec 2025
- First submitted
- 6 Jan 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Racodon M, Fabre C, Vanhove P, Vale JD, Bolpaire R, Moutailler E, Malanda F, Secq A. Validity and Reproducibility of the Six-Minute Stepper Test in Cardiac Patients. J Cardiovasc Transl Res. 2025 Aug;18(4):993-1000. doi: 10.1007/s12265-025-10624-z. Epub 2025 May 8.
PubMed 40341471
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)
- ClinicalTrials.gov ID
- NCT04699136
- Acronym / sponsor ID
- STEPPER / RC-P0087
- Conditions
- Cardiac Disease
- Keywords
- Cardiovascular rehabilitation, Stepper test, 6-minute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 7 Jan 2021 (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.
The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients
Detailed description
The 6-minute stepper test (ST6) is an test used and validated in patients with respiratory disorders (chronic obstructive pulmonary disease) in order to evaluate their tolerance to exercise. It is well tolerated and reproducible in these patients, with the advantage that it can be performed without spatial constraints.
However, this test is not yet used in cardiology. This study proposes to validate the ST6, to evaluate the exercise tolerance of patients suffering from cardiovascular pathologies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular disease | Experimental | Other: 6 minutes step test (ST6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old,
- Patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty),
- Registered in Cardiovascular Rehabilitation at the Mitterie Clinic,
- Number of rehabilitation sessions at least equal to 30,
- Ejection fraction ≥ 45%,
Key exclusion criteria (15 listed)
- Cardiac decompensation,
- Severe functional limitation,
- Unstable acute coronary syndrome,
- Decompensated heart failure,
- Severe ventricular rhythm disorders,
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 |
|---|---|---|
| 6 minutes step test (ST6)Performing a 6 minutes step test at different intervals and comparing with respect with the 6 minutes walk test and cardiac stress test | Other | Cardiovascular disease |
Primary outcome
Internal validity of the 6 minutes step test (ST6)
Time frame: Day 0
The number of steps taken in 6 minutes with the ST6 will be measured twice on the first day of the cardiovascular rehabilitation and education. The second ST6 will be performed 30 minutes after the first. Internal validity will be studied by calculating the intra-class correlation coefficient (ICC) of the number of steps from the two ST6 carried out and its 95% confidence interval.
External validity of the ST6 with respect to the 6 minutes walk test (WT6)
Time frame: Day 0
The external validity with respect to the (6 minutes walk test) WT6 will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the distance travelled in meters from the WT6.
3 secondary outcomes
External validity of the ST6 with respect to the cardiac stress test
Time frame: Day 0
External validity of the ST6 with respect to the Oxygen saturation at rest.
Time frame: Day 0
External validity of the ST6 with respect to the heart rate at maximum effort
Time frame: Day 0
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 24 Dec 2025.
- Results publication: PubMed 40341471Racodon M, Fabre C, Vanhove P, Vale JD, Bolpaire R, Moutailler E, Malanda F, Secq A. Validity and Reproducibility of the Six-Minute Stepper Test in Cardiac Patients. J Cardiovasc Transl Res. 2025 Aug;18(4):993-1000. doi: 10.1007/s12265-025-10624-z. Epub 2025 May 8.
- Individual participant dataSharing planned: No
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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.
Amandine SECQ, MD principal investigator
Clinique de la Mitterie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minutes step test (ST6) in people with Cardiac Disease, run by Lille Catholic University 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 7 inclusion and 15 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 24 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?
Internal validity of the 6 minutes step test (ST6) (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT04699136, 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 24 Dec 2025.