Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient (HRV-Predict)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standardized exercise training
HRV-guided exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary Artery Diseases, Cardiac rehabilitation, exercise training, heart rate variability, cognitive performance
Eligibility Criteria
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
Sites / Locations
- Preventive medicine and physical activity centre (centre EPIC), Montreal Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard exercise training
HRV-guided exercise training
Arm Description
The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months.
The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months.
Outcomes
Primary Outcome Measures
Change in cardiorespiratory fitness
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))
Responders and non-responders proportion
Proportion in each group (%) Responders will be defined as an increased of 5% of VO2max.
Secondary Outcome Measures
Parasympathetic activity
Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)
Parasympathetic activity
High Frequency power ( HF) of heart rate variability (ms2)
heart rate variability
Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms)
Baroreflex gain
Baroreflex sensibility (ms/mmHg)
Change in general cognitive functioning
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Change in processing speed
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in executive functions
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in episodic memory
Validated remote version of neuropsychological tests (Composite Z-score).
Full Information
NCT ID
NCT04971707
First Posted
July 12, 2021
Last Updated
September 2, 2021
Sponsor
Montreal Heart Institute
Collaborators
Fonds de la Recherche en Santé du Québec
1. Study Identification
Unique Protocol Identification Number
NCT04971707
Brief Title
Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
Acronym
HRV-Predict
Official Title
Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute
Collaborators
Fonds de la Recherche en Santé du Québec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Diseases, Cardiac rehabilitation, exercise training, heart rate variability, cognitive performance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment, 2 groups (1:1)
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard exercise training
Arm Type
Active Comparator
Arm Description
The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months.
Arm Title
HRV-guided exercise training
Arm Type
Experimental
Arm Description
The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months.
Intervention Type
Other
Intervention Name(s)
Standardized exercise training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HRV-guided exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cardiorespiratory fitness
Description
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))
Time Frame
Baseline and post-intervention at 3 months
Title
Responders and non-responders proportion
Description
Proportion in each group (%) Responders will be defined as an increased of 5% of VO2max.
Time Frame
Baseline and post-intervention at 3 months
Secondary Outcome Measure Information:
Title
Parasympathetic activity
Description
Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)
Time Frame
Baseline and post-intervention at 3 months
Title
Parasympathetic activity
Description
High Frequency power ( HF) of heart rate variability (ms2)
Time Frame
Baseline and post-intervention at 3 months
Title
heart rate variability
Description
Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms)
Time Frame
Baseline and post-intervention at 3 months
Title
Baroreflex gain
Description
Baroreflex sensibility (ms/mmHg)
Time Frame
Baseline and post-intervention at 3 months
Title
Change in general cognitive functioning
Description
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Time Frame
Baseline and post-intervention at 3 months
Title
Change in processing speed
Description
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Time Frame
Baseline and post-intervention at 3 months
Title
Change in executive functions
Description
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Time Frame
Baseline and post-intervention at 3 months
Title
Change in episodic memory
Description
Validated remote version of neuropsychological tests (Composite Z-score).
Time Frame
Baseline and post-intervention at 3 months
Other Pre-specified Outcome Measures:
Title
Change in anxiety
Description
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
Title
Change in depressive symptoms
Description
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
Title
Change in sleep quality
Description
Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). symptomatology). symptomatology).
Time Frame
Baseline and post-intervention at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florent Besnier, PhD
Phone
+1 514-374-1480
Ext
4333
Email
florent.besnier@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Louis Bherer, PhD
Phone
+1 514-374-1480
Ext
4355
Email
louis.bherer@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Bherer, PhD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T1N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Bherer, PhD
Phone
514-374-1480
Ext
4355
Email
louis.bherer@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Louis Bherer, PhD
First Name & Middle Initial & Last Name & Degree
Anil Nigam, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient
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