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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Standardized exercise training; Other: HRV-guided exercise training

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T1N6
      • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Collaborators: Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Louis Bherer, PhD, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac rehabilitation; exercise training; cognitive performance; heart rate variability; Coronary Artery Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2021-2897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No