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

NCT04699136 | Completed

• 2 other identifiers: RC-P00872019-A02483-54
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Disease

Keywords

Cardiovascular rehabilitation; Stepper test; 6-minute

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 0

Secondary Outcomes (3)

• External validity of the ST6 with respect to the cardiac stress test

  Day 0

• External validity of the ST6 with respect to the Oxygen saturation at rest.

  Day 0

• External validity of the ST6 with respect to the heart rate at maximum effort

  Day 0

Study Arms (1)

Cardiovascular disease

EXPERIMENTAL

Other: 6 minutes step test (ST6)

Interventions

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

Cardiovascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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),
• 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)

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Clinique de la Mitterie

Lille, 59160, France

Location

Related Publications (1)

• 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.

  PMID: 40341471 RESULT

MeSH Terms

Conditions

Heart Diseases

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Amandine SECQ, MD

  Clinique de la Mitterie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: January 13, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)