Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
- Conditions
- Coronary Artery Disease
- Interventions
- Other: Standardized exercise trainingOther: HRV-guided exercise training
- Registration Number
- NCT04971707
- Lead Sponsor
- Montreal Heart Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard exercise training Standardized exercise training The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months. HRV-guided exercise training HRV-guided exercise training The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Change in executive functions Baseline and post-intervention at 3 months Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
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)
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 episodic memory Baseline and post-intervention at 3 months Validated remote version of neuropsychological tests (Composite Z-score).
Baroreflex gain Baseline and post-intervention at 3 months Baroreflex sensibility (ms/mmHg)
Change in processing speed Baseline and post-intervention at 3 months Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Trial Locations
- Locations (1)
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada