Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability (HRV REEDUC)
Primary Purpose
Myocardial Infarction, Cardiac Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HRV measurement
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Cardiac rehabilitation, myocardial infarction, heart rate variability, physical fitness
Eligibility Criteria
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
Sites / Locations
- Chu Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
control
study strategy
Arm Description
standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.
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).
Outcomes
Primary Outcome Measures
gain of VO2max
The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT03745742
First Posted
November 15, 2018
Last Updated
November 22, 2018
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Clinique cardio-pneumologique de Durtol, Almerys
1. Study Identification
Unique Protocol Identification Number
NCT03745742
Brief Title
Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
Acronym
HRV REEDUC
Official Title
Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Clinique cardio-pneumologique de Durtol, Almerys
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Cardiac Rehabilitation
Keywords
Cardiac rehabilitation, myocardial infarction, heart rate variability, physical fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Other
Arm Description
standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.
Arm Title
study strategy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
HRV measurement
Other Intervention Name(s)
Rehabilitation program based on HRV measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
gain of VO2max
Description
The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max
Time Frame
after 4 weeks of cardiac rehabilitation
Secondary Outcome Measure Information:
Title
patients'quality of life after 4 weeks of cardiac rehabilitation
Description
The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.
Time Frame
after 4 weeks of cardiac rehabilitation
Title
The patient's functional capacity after 4 weeks of cardiac rehabilitation estimated by the distance covered during the 6-minute walk test.
Description
The gain in meter at the 6 minutes' walk test
Time Frame
after 4 weeks of cardiac rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D'Agrosa Boiteux Marie-Claire
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
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Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
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