Coronary Artery Disease
Conditions
Keywords
Coronary Artery Diseases, Cardiac rehabilitation, exercise training, heart rate variability, cognitive performance
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.
Interventions
OTHERStandardized 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.
OTHERHRV-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.
Sponsors
Fonds de la Recherche en Santé du Québec
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
parallel assignment, 2 groups (1:1)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| heart rate variability | Baseline and post-intervention at 3 months | Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms) |
| Baroreflex gain | Baseline and post-intervention at 3 months | Baroreflex sensibility (ms/mmHg) |
| 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). |
| Parasympathetic activity | Baseline and post-intervention at 3 months | Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms) |
| Change in processing speed | Baseline and post-intervention at 3 months | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). |
| Change in executive functions | Baseline and post-intervention at 3 months | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). |
| Change in episodic memory | Baseline and post-intervention at 3 months | Validated remote version of neuropsychological tests (Composite Z-score). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety | Baseline and post-intervention at 3 months | State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety). |
| Change in depressive symptoms | Baseline and post-intervention at 3 months | Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology). |
| Change in sleep quality | Baseline and post-intervention at 3 months | Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). symptomatology). symptomatology). |
Countries
Canada
Outcome results
None listed