NCT03745742: HRV REEDUC

Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

Completed NA Last updated 26 November 2018

What this trial tests

NA trial testing HRV measurement in Myocardial Infarction in 80 participants. Completed in 30 September 2017.

Timeline

1 March 2016

Primary endpoint
31 August 2017

30 September 2017

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 March 2016
Primary completion	31 August 2017
Estimated completion	30 September 2017
Sites	1 location across France

Drugs / interventions tested

• HRV measurement

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →
• Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

Adults 18 to 70, any sex, with Myocardial Infarction or Cardiac Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. mHealth system (ATOPE+) to support exercise prescription in breast cancer survivors: a reliability and validity, cross-sectional observational study (ATOPE study).
   Postigo-Martin P, Gil-Gutiérrez R, Moreno-Gutiérrez S, Lopez-Garzon M, et al · · 2022 · cited 5× · PMID 36076044 · DOI 10.1038/s41598-022-18706-7