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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2022

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Parasympathetic activity
    • Time Frame: Baseline and post-intervention at 3 months
    • Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)
  • Parasympathetic activity
    • Time Frame: Baseline and post-intervention at 3 months
    • High Frequency power ( HF) of heart rate variability (ms2)
  • heart rate variability
    • Time Frame: Baseline and post-intervention at 3 months
    • Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms)
  • Baroreflex gain
    • Time Frame: Baseline and post-intervention at 3 months
    • Baroreflex sensibility (ms/mmHg)
  • Change in general cognitive functioning
    • Time Frame: 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
    • Time Frame: Baseline and post-intervention at 3 months
    • Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
  • Change in executive functions
    • Time Frame: Baseline and post-intervention at 3 months
    • Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
  • Change in episodic memory
    • Time Frame: Baseline and post-intervention at 3 months
    • Validated remote version of neuropsychological tests (Composite Z-score).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Montreal Heart Institute
  • Collaborator
    • Fonds de la Recherche en Santé du Québec
  • Provider of Information About this Clinical Study
    • Principal Investigator: Louis Bherer, Associate scientific director, Direction of prevention, Montreal Heart Institute – Montreal Heart Institute
  • Overall Official(s)
    • Louis Bherer, PhD, Principal Investigator, Montreal Heart Institute
  • Overall Contact(s)
    • Florent Besnier, PhD, +1 514-374-1480, florent.besnier@umontreal.ca

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