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OpenTrials
Completed

NCT Number: NCT03745742

Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

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.

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Key information

Conditions

Myocardial Infarction Cardiac Rehabilitation Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRV measurement

Other

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

Primary outcomes

  1. gain of VO2max

    Time frame: after 4 weeks of cardiac rehabilitation

    The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max

Secondary outcomes

  1. patients'quality of life after 4 weeks of cardiac rehabilitation

    Time frame: 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.

  2. The patient's functional capacity after 4 weeks of cardiac rehabilitation estimated by the distance covered during the 6-minute walk test.

    Time frame: after 4 weeks of cardiac rehabilitation

    The gain in meter at the 6 minutes' walk test

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Almerys
  • Clinical Of Medical Cardio Pneumologie, Durtol

Registry information

Acronym: HRV REEDUC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 19, 2018
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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