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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Periodization of Exercise Training in Patients With Coronary Heart Disease.

NCT03443193

Coronary Heart Disease Healthy Control

COMPLETED NA

Effects of Heart Rate Variability-guided Training vs Standard Aerobic Prescription on Cardiovagal Modulation and Cardiorespiratory Fitness in Coronary Artery Disease

NCT06919237

Coronary Arterial Disease (CAD)

NOT_YET_RECRUITING NA

Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction

NCT02048696

Myocardial Infarction Heart Failure Coronary Artery Disease

COMPLETED NA

Heart Rate Variability-guided Training in Cardiac Rehabilitation

NCT04930939

Coronary Artery Disease

COMPLETED NA

High-intensity Interval Training in Patients With Post-acute Coronary Syndrome

NCT03414996

Acute Coronary Syndrome Arrhythmia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment, 2 groups (1:1)

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard exercise training

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

Group Type ACTIVE_COMPARATOR

Standardized exercise training

Intervention Type OTHER

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.

HRV-guided exercise training

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

Group Type EXPERIMENTAL

HRV-guided exercise training

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No