Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability (HRV REEDUC)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Cardiac Rehabilitation; Myocardial Infarction

Treatments: Other: HRV measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03745742

CHU-417

2015-AO1755-44 (Other Identifier)

Details and patient eligibility

About

Cardiac rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. A smartphone app can measure the HRV via a heart rate monitor.

The main study objective is to compare the effect on the functional capacities of a re-training adapted to the HRV compared to a standard program in the post-MI The secondary objective is to compare the patients' quality of life according to the rehabilitation program and to validate the HRV smartphone app.

This is a prospective, multicenter study. Post-MI patients treated with angioplasty with a LVEF> 40% are randomized into 2 groups: HRV (re-training adapted to HRV daily: 10W decrease or increase in workload according to the HRV) or control (continuous training in SV1). Patients underwent a cardiopulmonary test, a walking test (TM6) and a SF36 questionaries' at the entrance and exit. The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.

Full description

Description of the study:

Patients with myocardial infarction (STEMI or NSTEMI) without alteration of left ventricle systolic function, agreeing to participate at a cardiac rehabilitation program will be included in the study and randomized into two groups:

• Group A (= control): standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.)
• Group B (= strategy to the study): individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning).

The duration of the rehabilitation program will be 4 weeks with 5 training sessions per week (Monday to Friday), or 20 training sessions. At the end of the program, patients will benefit from an assessment of functional abilities and their quality of life.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man, Woman ≥18 years old and <70 years old
• STEMI or NSTEMI having undergone angioplasty revascularization at least 8 day before the beginning of reeducation
• Sinus rhythm
• LVEF> 40% (Simpson Biplane echocardiography

Exclusion criteria

• Contraindications to cardiac re-training:
• Ventricular or supraventricular rhythm disorder
• Heart failure.
• Pericardial effusion.
• STEMI or NSTEMI <J8
• NSTEMI or STEMI , post revascularization by bypass surgery
• Non-sinus rhythm
• Comorbidity preventing all sports activity: severe AOMI; amputation; neurological disorder, hemiplegia.
• Pathology leading to modifications of the HRV:
• Chronic lung disease
• Renal insufficiency with clearance <30 ml / min (MDRD)
• LVEF <40%
• Electrical cardiac stimulation
• Linked to the person:
• Protected Majors
• People unable to express their consent.
• Pregnant woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

control

Other group

Description:

standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.

Treatment:

Other: HRV measurement

study strategy

Experimental group

Description:

individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning).

Treatment:

Other: HRV measurement