Clinical trial NCT03745742: Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
Official title: Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Cardiac Rehabilitation
Keywords: Cardiac rehabilitation
myocardial infarction
heart rate variability
physical fitness
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Clinique cardio-pneumologique de Durtol
name: Almerys
First posted: 2018-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: gain of VO2max
timeFrame: after 4 weeks of cardiac rehabilitation
Secondary outcomes:
measure: patients'quality of life after 4 weeks of cardiac rehabilitation
timeFrame: after 4 weeks of cardiac rehabilitation
measure: The patient's functional capacity after 4 weeks of cardiac rehabilitation estimated by the distance covered during the 6-minute walk test.
timeFrame: after 4 weeks of cardiac rehabilitation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: D'Agrosa Boiteux Marie-Claire
role: PRINCIPAL_INVESTIGATOR
References: