Coronary Artery DiseaseHRV-PredictNCT04971707
Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
A study testing Standardized exercise training and HRV-guided exercise training in people with Coronary Artery Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Standardized exercise training and HRV-guided exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Standardized exercise training, HRV-guided exercise training
- Keywords
- Coronary Artery Diseases, Cardiac rehabilitation, exercise training, heart rate variability, cognitive performance
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized exercise trainingOther
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-guided exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| standard exercise training | Active comparator | The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months. Receives: Other: Standardized exercise training |
| HRV-guided exercise training | Experimental | The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months. Receives: Other: HRV-guided exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))
Measured: 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.
Measured: Baseline and post-intervention at 3 months
Secondary outcomes (8)
Parasympathetic activity
Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)
Measured: Baseline and post-intervention at 3 months
Parasympathetic activity
High Frequency power ( HF) of heart rate variability (ms2)
Measured: Baseline and post-intervention at 3 months
heart rate variability
Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms)
Measured: Baseline and post-intervention at 3 months
Baroreflex gain
Baroreflex sensibility (ms/mmHg)
Measured: 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).
Measured: Baseline and post-intervention at 3 months
Change in processing speed
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Measured: Baseline and post-intervention at 3 months
Change in executive functions
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Measured: Baseline and post-intervention at 3 months
Change in episodic memory
Validated remote version of neuropsychological tests (Composite Z-score).
Measured: Baseline and post-intervention at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Aug 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment, 2 groups (1:1)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Louis Bherer, Montreal Heart Institute
- Investigators
- Louis Bherer, PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971707
- Sponsor's protocol ID
- 2021-2897
- Acronym
- HRV-Predict
- Status last verified
- Jan 2024
- First submitted
- 12 Jul 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
- ClinicalTrials.gov ID
- NCT04971707
- Acronym / sponsor ID
- HRV-Predict / 2021-2897
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Diseases, Cardiac rehabilitation, exercise training, heart rate variability, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment, 2 groups (1:1)
| Arm | Type | Receives |
|---|---|---|
| standard exercise training | Active comparator | Other: Standardized exercise trainingThe physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months. |
| HRV-guided exercise training | Experimental | Other: HRV-guided exercise trainingThe physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized exercise trainingHRV 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. | Other | standard exercise training |
| HRV-guided exercise trainingHRV 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. | Other | HRV-guided exercise training |
Primary outcome
Change in cardiorespiratory fitness
Time frame: Baseline and post-intervention at 3 months
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))
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.
8 secondary outcomes
Parasympathetic activity
Time frame: Baseline and post-intervention at 3 months
Parasympathetic activity
Time frame: Baseline and post-intervention at 3 months
heart rate variability
Time frame: Baseline and post-intervention at 3 months
Baroreflex gain
Time frame: Baseline and post-intervention at 3 months
Change in general cognitive functioning
Time frame: Baseline and post-intervention at 3 months
Change in processing speed
Time frame: Baseline and post-intervention at 3 months
Change in executive functions
Time frame: Baseline and post-intervention at 3 months
Change in episodic memory
Time frame: Baseline and post-intervention at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Bherer, PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized exercise training and HRV-guided exercise training in people with Coronary Artery Disease, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness (time frame: Baseline and post-intervention at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.