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| Name | Class |
|---|---|
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard exercise training | Active Comparator | The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months. |
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| HRV-guided exercise training | Experimental | The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized exercise training | 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. |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Bherer, PhD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute | Montreal | Quebec | H1T1N6 | Canada |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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parallel assignment, 2 groups (1:1)
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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.
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| HRV-guided exercise training | 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. |
|
| 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 |
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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |