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

Lille Catholic University

Status: Completed

Conditions: Cardiac Disease

Treatments: Other: 6 minutes step test (ST6)

Study type: Interventional

Funder types: Other

Identifiers

NCT04699136

2019-A02483-54 (Other Identifier)

RC-P0087

Details and patient eligibility

About

The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Cardiovascular disease

Experimental group

Treatment:

Other: 6 minutes step test (ST6)