Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6, Canada
NCT Number: NCT04971707
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H1T1N6, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: Baseline and post-intervention at 3 months
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))
Time frame: Baseline and post-intervention at 3 months
Proportion in each group (%) Responders will be defined as an increased of 5% of VO2max.
Time frame: Baseline and post-intervention at 3 months
Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)
Time frame: Baseline and post-intervention at 3 months
High Frequency power ( HF) of heart rate variability (ms2)
Time frame: Baseline and post-intervention at 3 months
Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms)
Time frame: Baseline and post-intervention at 3 months
Baroreflex sensibility (ms/mmHg)
Time frame: Baseline and post-intervention at 3 months
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Time frame: Baseline and post-intervention at 3 months
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Time frame: Baseline and post-intervention at 3 months
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Time frame: Baseline and post-intervention at 3 months
Validated remote version of neuropsychological tests (Composite Z-score).
Time frame: Baseline and post-intervention at 3 months
State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).
Time frame: Baseline and post-intervention at 3 months
Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).
Time frame: 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).
Montreal Heart Institute
Other
Acronym: HRV-Predict
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