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Completed

NCT Number: NCT04971707

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized exercise training

Other

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

Other

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 outcomes

  1. Change in cardiorespiratory fitness

    Time frame: Baseline and post-intervention at 3 months

    Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))

  2. 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.

Secondary outcomes

  1. Parasympathetic activity

    Time frame: Baseline and post-intervention at 3 months

    Root Mean Square of the Successive Differences ( RMSSD) of heart rate variability (ms)

  2. Parasympathetic activity

    Time frame: Baseline and post-intervention at 3 months

    High Frequency power ( HF) of heart rate variability (ms2)

  3. 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)

  4. Baroreflex gain

    Time frame: Baseline and post-intervention at 3 months

    Baroreflex sensibility (ms/mmHg)

  5. 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).

  6. 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).

  7. Change in executive functions

    Time frame: Baseline and post-intervention at 3 months

    Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

  8. Change in episodic memory

    Time frame: Baseline and post-intervention at 3 months

    Validated remote version of neuropsychological tests (Composite Z-score).

Other outcomes

  1. 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).

  2. Change in depressive symptoms

    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).

  3. Change in sleep quality

    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).

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec

Registry information

Acronym: HRV-Predict

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2021
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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