Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

Myocardial Infarction Clinical Trial

— HRV REEDUC  

Official title:

Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745742
• Other study ID #: CHU-417
• Secondary ID: 2015-AO1755-44
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: November 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Almerys, Clinique cardio-pneumologique de Durtol

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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