Clinical trial NCT04971707: Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
Official title: Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Diseases
Cardiac rehabilitation
exercise training
heart rate variability
cognitive performance
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2021-07-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment, 2 groups (1:1)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and post-intervention at 3 months
measure: Responders and non-responders proportion
timeFrame: Baseline and post-intervention at 3 months
Secondary outcomes:
measure: Parasympathetic activity
timeFrame: Baseline and post-intervention at 3 months
measure: Parasympathetic activity
timeFrame: Baseline and post-intervention at 3 months
measure: heart rate variability
timeFrame: Baseline and post-intervention at 3 months
measure: Baroreflex gain
timeFrame: Baseline and post-intervention at 3 months
measure: Change in general cognitive functioning
timeFrame: Baseline and post-intervention at 3 months
measure: Change in processing speed
timeFrame: Baseline and post-intervention at 3 months
measure: Change in executive functions
timeFrame: Baseline and post-intervention at 3 months
measure: Change in episodic memory
timeFrame: Baseline and post-intervention at 3 months
Other outcomes:
measure: Change in anxiety
timeFrame: Baseline and post-intervention at 3 months
measure: Change in depressive symptoms
timeFrame: Baseline and post-intervention at 3 months
measure: Change in sleep quality
timeFrame: Baseline and post-intervention at 3 months
Locations:
city: Montreal
country: Canada
facility: Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Louis Bherer, PhD
role: PRINCIPAL_INVESTIGATOR
References: