Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
Condition: Myocardial Infarction; Cardiac Rehabilitation
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

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.
    

Intervention name(s): HRV measurement
Intervention type(s): Other
Intervention description(s): Patients in group A (control) will benefit from a standard re-training protocol based on initial functional abilities. The training is done at a target heart rate corresponding to the heart rate reached at the first ventilatory threshold (about 55% of VO2max).
Patients in group B (study strategy) will benefit from a re-training protocol based on HRV and initial functional abilities. Any increase in HRV compared to the previous day will result in an increase in workload of 10Watt. Any increase or decrease in HRV for 3 days in a row will cause the stagnation of the workload for 2 days.
HRV is measured every day in each group via a heart rate belt and a smartphone App.
Other intervention name(s): Rehabilitation program based on HRV measurement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cardiac rehabilitation; myocardial infarction; heart rate variability; physical fitness