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

Not Applicable

Completed

• Conditions: Cardiac Disease
• Interventions: Other: 6 minutes step test (ST6)

• Registration Number: NCT04699136
• Lead Sponsor: Lille Catholic University

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.

Study Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Study Start: 2021-01-13
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiovascular disease	6 minutes step test (ST6)	-

Primary Outcome Measures

Name	Time	Method
Internal validity of the 6 minutes step test (ST6)	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)	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.

Secondary Outcome Measures

Name	Time	Method
External validity of the ST6 with respect to the cardiac stress test	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.
External validity of the ST6 with respect to the Oxygen saturation at rest.	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.
External validity of the ST6 with respect to the heart rate at maximum effort	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.

Trial Locations

Locations (1)

Clinique de la Mitterie; 🇫🇷 Lille, France