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

NCT ID: NCT04699136

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2022-04-28

Brief 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

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

Keywords

Cardiovascular rehabilitation; Stepper test; 6-minute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cardiovascular disease

Group Type: EXPERIMENTAL

6 minutes step test (ST6)

Intervention Type: OTHER

Performing a 6 minutes step test at different intervals and comparing with respect with the 6 minutes walk test and cardiac stress test

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amandine SECQ, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique de la Mitterie

Locations

Clinique de la Mitterie

Lille, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 40341471 (View on PubMed)

Other Identifiers

2019-A02483-54

Identifier Type: OTHER

Identifier Source: secondary_id

RC-P0087

Identifier Type: -

Identifier Source: org_study_id