An interventional study of HRV measurement in Myocardial Infarction and Cardiac Rehabilitation, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-26.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment
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.
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:
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.
2,779 studies on the registry are indexed under Myocardial Infarction; 417 are open to participants now.
This study's enrollment of 80 is below the median of 148 across 1,613 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.
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Exclusion Criteria:
standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.
Other: HRV measurement
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).
Other: HRV measurement
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.
Also known as: Rehabilitation program based on HRV measurement
gain of VO2max
The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max
Time frame: after 4 weeks of cardiac rehabilitation
patients'quality of life after 4 weeks of cardiac rehabilitation
The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.
Time frame: after 4 weeks of cardiac rehabilitation
The patient's functional capacity after 4 weeks of cardiac rehabilitation estimated by the distance covered during the 6-minute walk test.
The gain in meter at the 6 minutes' walk test
Time frame: after 4 weeks of cardiac rehabilitation
Ran from Mar 2016 to primary completion in Aug 2017, 17 months.
Of 402 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's 17 months is below that.
Counting every sponsor, half of 438 studies reached it within 32 months; a quarter within 15 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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