HRV-Predict: Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient

Sponsor

Montreal Heart Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04971707

Collaborator

Fonds de la Recherche en Santé du Québec (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: Standardized exercise training Other: HRV-guided exercise training	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel assignment, 2 groups (1:1)parallel assignment, 2 groups (1:1)

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

This clinical trial is a double-blinded study. Patients, and research personnel performing the outcome assessments and investigators will be blinded to group allocation. Only the kinesiologists will be aware of the group allocation.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: standard exercise training The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months.	Other: Standardized exercise training 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.
Experimental: HRV-guided exercise training The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months.	Other: HRV-guided exercise training 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.

Arm

Intervention/Treatment

Active Comparator: standard exercise training

The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months.

Other: Standardized exercise training

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.

Experimental: HRV-guided exercise training

The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months.

Other: HRV-guided exercise training

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Change in anxiety [Baseline and post-intervention at 3 months]
State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).
Change in depressive symptoms [Baseline and post-intervention at 3 months]
Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).
Change in sleep quality [Baseline and post-intervention at 3 months]
Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). symptomatology). symptomatology).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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