Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient

Coronary Artery Disease Clinical Trial

— HRV-Predict  

Official title:

Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971707
• Other study ID #: 2021-2897
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Standardized exercise training
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 training
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.

Locations

Country	Name	City	State
Canada	Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in depressive symptoms	Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).	Baseline and post-intervention at 3 months
Other	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
Primary	Change in cardiorespiratory fitness	Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))	Baseline and post-intervention at 3 months
Primary	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
Secondary	Parasympathetic activity	Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)	Baseline and post-intervention at 3 months
Secondary	Parasympathetic activity	High Frequency power ( HF) of heart rate variability (ms2)	Baseline and post-intervention at 3 months
Secondary	heart rate variability	Global heart rate variability : standard deviation of the normal sinus beats (SDNN, ms)	Baseline and post-intervention at 3 months
Secondary	Baroreflex gain	Baroreflex sensibility (ms/mmHg)	Baseline and post-intervention at 3 months
Secondary	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
Secondary	Change in processing speed	Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).	Baseline and post-intervention at 3 months
Secondary	Change in executive functions	Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).	Baseline and post-intervention at 3 months
Secondary	Change in episodic memory	Validated remote version of neuropsychological tests (Composite Z-score).	Baseline and post-intervention at 3 months