Clinical trial NCT04699136: Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test
Official title: Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Keywords: Cardiovascular rehabilitation
Stepper test
6-minute
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Internal validity of the 6 minutes step test (ST6)
timeFrame: Day 0
measure: External validity of the ST6 with respect to the 6 minutes walk test (WT6)
timeFrame: Day 0
Secondary outcomes:
measure: External validity of the ST6 with respect to the cardiac stress test
timeFrame: Day 0
measure: External validity of the ST6 with respect to the Oxygen saturation at rest.
timeFrame: Day 0
measure: External validity of the ST6 with respect to the heart rate at maximum effort
timeFrame: Day 0
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinique de la Mitterie
Study officials:
affiliation: Clinique de la Mitterie
name: Amandine SECQ, MD
role: PRINCIPAL_INVESTIGATOR
References: