Comparison of Two Exercise Training Modes on Left Myocardial Regional Function After Myocardial Infarction Evaluated by 2D Strain Ultrasound
Condition: Ischemic Cardiomyopathy
MeSH terms: Myocardial Infarction; Cardiomyopathies; Infarction
Study type: Observational

Summary: 
      Ischemic cardiomyopathy, defined by a deficiency in oxygenation of the myocardium due to a
      narrowing of the coronary arteries, is a major problem for public health. Medicinally-treated
      or re-vascularized cardiovascular rehabilitation following myocardial infarction has shown
      undeniable benefits in decreasing the overall mortality rate (13-26%), cardiovascular
      mortality (26-36%) and morbidity, by controlling cardiovascular risk factors and improving
      tolerance to effort and consequently improving the quality of life. Since the integration of
      physical exercise into the rehabilitation programs of patients suffering from coronary
      disease in the mid-90s, and throughout the following decade, the exercise training program
      has mainly relied on moderately intense continuous exercises (CONT) the aim of which is to
      improve the aerobic capacity. These efforts typically consist of performing a submaximal
      exercise with an intensity of 50 to 80% of the maximum capacity for effort (established
      according to studies depending on the maximum or reserve heart rate or even peak power,
      measured when performing a first test, then a progressive and maximum test), and a constant
      duration (about 20 to 60 minutes). In the 2000s, under the aegis of Scandinavian teams, the
      intermittent mode (IT) appeared, characterized by alternating high intensity efforts of a
      short duration with active recuperation phases (Rognmo et al., 2004). Superiority of the IT
      mode over the CONT mode is generally observed on aerobic capacity for effort, usually gauged
      via the maximal oxygen consumption peak measured during a graded and maximum effort test. An
      important methodological bias in the comparison of the two modalities, within meta-analyses
      or even in the same randomized controlled trial, is the absence of control/pairing on the
      overall volume of training. At the present time, and to the best of our knowledge, there have
      been no studies to compare the effects of CONT versus IT modes on the systolic or diastolic
      function of the myocardial region by 2D-strain following myocardial infarction. The aim of
      our study was to compare the outcomes of 2D strain scans upon inclusion and after 8 weeks of
      cardiovascular physiotherapy for 2 groups of patients benefiting from a CONT or IT program.
    

Detailed description: 
      This is a bi-centric randomised comparative superiority trial, blinded to the evaluator for 2
      parallel groups (interventional intermittent training group "IT" vs a continuous training
      control group "CONT") with a 1:1 ratio.

      Patients admitted for care at the cardiology departments of Nîmes University Hospital and the
      cardiology department of Avignon hospital for a first myocardial infarction dating back to
      less than 6 weeks will be pre-selected. The patients will receive both written and oral
      information about the study.

      Patients are then referred to the Physical Medicine and Cardiac Rehabilitation departments at
      Nîmes University Hospital for the Nîmes site and the Lavarin Cardio Rehabilitation Center for
      the Avignon site for the inclusion visit at which the information about the study is given.
      Patients will be included in the study after signing a consent form.

      The investigators then proceed with a maximal aerobic exercise test to evaluate
      cardiovascular endurance capacities and the suitability of the cardiovascular training
      program. Cardiac ultrasound is also performed, questionnaires about the quality of life are
      administered and biological doses are measured.

      Then a stratified randomisation on the patient's age and sex will be performed to assign the
      subject either to the "IT intermittent training group" group, the experimental group, or to
      the "CONT continuous training" group, the control group which corresponds to the general care
      usually given.

      Comparison of these two groups constitutes the methodological framework for this research. In
      the "IT intermittent training group (the experimental group), the patient benefits from a
      retraining program according to intermittent mode for 8 weeks, with three 45-minute sessions
      per week.

      In the "CONT continuous training" group (the control group), the patient benefits from a
      retraining program according to the continuous mode for 8 weeks, with three 40-minute
      sessions per week.

      At the end of the retraining program, at 8 weeks, an exercise test and a 2D Strain scan are
      performed, biological doses are taken and quality of life questionnaires are handed out.

      Each patient will be followed 2 months after inclusion. The duration of inclusion period will
      be 18 months. The total duration of the test will be 24 months.
    

Intervention name(s): Intermittent retraining program.
Intervention type(s): Other
Intervention description(s): Patient benefits from an intermittent retraining program for 8 weeks, with three 45-minute sessions per week.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of patients aged 18 to 75 years old being cared for in
        cardiology departments due to a first myocardial infarction dating back to less than 6
        weeks.