Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test (STEPPER)

December 18, 2025 updated by: Lille Catholic University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

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

  • France
      • Lille, France, 59160
        • Clinique de la Mitterie

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:

  • 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.

Exclusion Criteria:

  • 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,
  • 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)

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiovascular disease
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External validity of the ST6 with respect to the cardiac stress test
Time Frame: Day 0
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.
Day 0
External validity of the ST6 with respect to the Oxygen saturation at rest.
Time Frame: Day 0
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.
Day 0
External validity of the ST6 with respect to the heart rate at maximum effort
Time Frame: Day 0
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.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Amandine SECQ, MD, Clinique de la Mitterie

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.

General Publications

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 (Actual)

January 13, 2021

Primary Completion (Actual)

April 28, 2022

Study Completion (Actual)

April 28, 2022

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0087
  • 2019-A02483-54 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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