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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Cardiac Rehabilitation
• Intervention / Treatment: Other: HRV measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU clermont-ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control; standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.	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.; Other Names: Rehabilitation program based on HRV measurement
Experimental: study strategy; 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.; Other Names: Rehabilitation program based on HRV measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gain of VO2max	The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max	after 4 weeks of cardiac rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	after 4 weeks of cardiac rehabilitation

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Clinique cardio-pneumologique de Durtol; Almerys
• Investigators: Principal Investigator: D'Agrosa Boiteux Marie-Claire, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: myocardial infarction; Cardiac rehabilitation; heart rate variability; physical fitness
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CHU-417; 2015-AO1755-44 (Other Identifier: 2015-AO1755-44)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No