Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient

Study Overview
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Brief Summary
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The objective of this project is to assess the effectiveness of a new modality of prescribing the intensity of physical exercise in cardiovascular rehabilitation programs according to physiological criteria (heart rate variability measured every morning) in comparison to a standard non-individualized program.

Detailed Description
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In coronary artery disease patients, cardiovascular rehabilitation (CR) reduces cardiac mortality by 30% when compared to usual drug therapy without CR. Cardiorespiratory fitness (VO2peak) is the most powerful independent prognostic marker of longevity. An improvement in VO2peak is also associated with better cognitive performance in the elderly. The effectiveness of CR varies between patients. About 25% of coronary disease patients do not improve their VO2peak after taking part of a CR program. The risk of acute event for those non-responder patients, (i.e. not increasing their VO2peak), is high with a mortality rate three times higher compared to responder individuals. It seems that the autonomic nervous system (ANS) is playing an important role in exercise training-induced physiological responses. Based on this, it has been proposed in healthy subjects to prescribe each exercise session according to ANS parameters (via heart rate variability, HRV). It has been suggested that high-intensity exercise when HRV parameters are stable, results in better adaptations to training. Conversely, recovery sessions when HRV is impaired seem necessary. 44 participants with stable coronary artery diseases, and taking part in a CR program will be included in this study. All participants will have signed a written consent form before taking part in the study. Patients will be randomly assigned to one of the 2 following study arms: 1/ standard exercise training ; 2/ Heart Rate Variability-guided exercise training.

Official Title
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Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Standardized exercise training
* Other: HRV-guided exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary artery disease patient from the Montreal Heart Institute Age> 18 years old Referred to the EPIC center in a cardiovascular rehabilitation program due to stable angina pectoris, acute coronary syndrome (with or without ST segment elevation) or after complete coronary revascularization (primary or elective) by Percutaneous Coronary Intervention. Able to perform a maximal cardiopulmonary exercise stress test in accordance with current cardiovascular rehabilitation recommendations. Able to read, understand and sign the information and consent form. Exclusion Criteria: Any absolute and relative contraindication to the maximal exercise test and / or physical activity. Recent cardiovascular events (cardiac decompensation or treatment with positive inotropic drugs or angioplasty less than 10 days, cardiac surgery less than 1 month, valve disease requiring surgical correction, active myopericarditis, severe ventricular arrhythmias not stabilized under treatment). Revascularization by coronary artery bypass grafting Atrial fibrillation Renal failure Heart failure Diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment, 2 groups (1:1)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard exercise training<br>The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months. | Other: Standardized exercise training<br>* HRV index will be measured every morning during 5 min. This group will benefit from the standard cardiovascular rehabilitation program combining both continuous moderate exercise sessions (MICT) and high intensity interval exercise sessions (HIIT). MICT sessions will be performed 2 times per week and HIIT sessions will be performed once a week.<br>|
| Experimental: HRV-guided exercise training<br>The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months. | Other: HRV-guided exercise training<br>* HRV index will be measured every morning during 5 min. This group will benefit from the individualized cardiovascular rehabilitation program. Daily exercise (MICT, HIIT, or active recovery) will be prescribed according to the HRV-index measured on the morning of the session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiorespiratory fitness | Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)) | Baseline and post-intervention at 3 months | 
| Responders and non-responders proportion | Proportion in each group (%) Responders will be defined as an increased of 5% of VO2max. | Baseline and post-intervention at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasympathetic activity | Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms) | Baseline and post-intervention at 3 months | 
| Parasympathetic activity | High Frequency power ( HF) of heart rate variability (ms2) | Baseline and post-intervention at 3 months | 
| heart rate variability | Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms) | Baseline and post-intervention at 3 months | 
| Baroreflex gain | Baroreflex sensibility (ms/mmHg) | Baseline and post-intervention at 3 months | 
| Change in general cognitive functioning | Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning). | Baseline and post-intervention at 3 months | 
| Change in processing speed | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 3 months | 
| Change in executive functions | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 3 months | 
| Change in episodic memory | Validated remote version of neuropsychological tests (Composite Z-score). | Baseline and post-intervention at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise training, heart rate variability, cognitive performance, Coronary Artery Diseases, Cardiac rehabilitation