- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04971707
Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient (HRV-Predict)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H1T1N6
- Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard exercise training
The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months.
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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.
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Experimental: HRV-guided exercise training
The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cardiorespiratory fitness
Time Frame: Baseline and post-intervention at 3 months
|
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))
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Baseline and post-intervention at 3 months
|
Responders and non-responders proportion
Time Frame: Baseline and post-intervention at 3 months
|
Proportion in each group (%) Responders will be defined as an increased of 5% of VO2max.
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Baseline and post-intervention at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parasympathetic activity
Time Frame: Baseline and post-intervention at 3 months
|
Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)
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Baseline and post-intervention at 3 months
|
Parasympathetic activity
Time Frame: Baseline and post-intervention at 3 months
|
High Frequency power ( HF) of heart rate variability (ms2)
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Baseline and post-intervention at 3 months
|
heart rate variability
Time Frame: Baseline and post-intervention at 3 months
|
Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms)
|
Baseline and post-intervention at 3 months
|
Baroreflex gain
Time Frame: Baseline and post-intervention at 3 months
|
Baroreflex sensibility (ms/mmHg)
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Baseline and post-intervention at 3 months
|
Change in general cognitive functioning
Time Frame: Baseline and post-intervention at 3 months
|
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
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Baseline and post-intervention at 3 months
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Change in processing speed
Time Frame: Baseline and post-intervention at 3 months
|
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
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Baseline and post-intervention at 3 months
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Change in executive functions
Time Frame: Baseline and post-intervention at 3 months
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Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
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Baseline and post-intervention at 3 months
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Change in episodic memory
Time Frame: Baseline and post-intervention at 3 months
|
Validated remote version of neuropsychological tests (Composite Z-score).
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Baseline and post-intervention at 3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxiety
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).
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Baseline and post-intervention at 3 months
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Change in depressive symptoms
Time Frame: Baseline and post-intervention at 3 months
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Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).
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Baseline and post-intervention at 3 months
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Change in sleep quality
Time Frame: Baseline and post-intervention at 3 months
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Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality).
symptomatology).
symptomatology).
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Baseline and post-intervention at 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Louis Bherer, PhD, Montreal Heart Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-2897
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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