Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

NCT03745742 | Completed

• 2 other identifiers: CHU-4172015-AO1755-44
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Infarction; Cardiac Rehabilitation

Keywords

Cardiac rehabilitation; myocardial infarction; heart rate variability; physical fitness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• patients'quality of life after 4 weeks of cardiac rehabilitation

  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.

  after 4 weeks of cardiac rehabilitation

Study Arms (2)

control

OTHER

standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.

Other: HRV measurement

study strategy

EXPERIMENTAL

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

Interventions

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.

Also known as: Rehabilitation program based on HRV measurement

control; study strategy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Clinique cardio-pneumologique de Durtol: collaborator
• Almerys: collaborator

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• D'Agrosa Boiteux Marie-Claire

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: March 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: September 30, 2017
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

FR (1)