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NCT Number: NCT06107452

Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability

Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, France

Location status: Recruiting

Location contact

David HUPIN, MD

PRINCIPAL_INVESTIGATOR

Frédéric ROCHE, MD PhD

SUB_INVESTIGATOR

About this study

Our study aims to evaluate the application of HRV in regulating training load based on fatigue levels in cardiac rehabilitation patients utilizing the PFVP framework.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >18
  • Acute Coronary Syndrome treated in the last 6 months
  • Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
  • Initial CPETt: MPA ≥ 60w in women and ≥80w in men
  • French
  • Informed consent

Exclusion criteria

  • Significant co-morbidities limited practice of physical activity

Treatment and study plan

training strategy with adaptation of training strategies to the ANS

Other

a training strategy for subjects whose PFVP is in favour of strength or speed with training load adjusted according to SNA

training strategy (standard practice)

Other

a training strategy for subjects whose PFVP is in favour of strength or speed

Primary outcomes

  1. The root mean square of successive differences in heart rate or RMSSD

    Time frame: Baseline to 2 months

    The root mean square of successive differences in heart rate or RMSSD will be measured from a nocturnal Holter ECG recording at the end of 8 weeks of exercise retraining and compared with the initial pre-training value. weeks of exercise re-training and compared with the initial pre-training value.

Secondary outcomes

  1. Value of maximum oxygen consumption

    Time frame: Baseline to 2 months

    VO2 max (ml/min/kg) thanks to 24-hour ECG recording

  2. Assessment of the ANS sympathetic branch

    Time frame: Baseline to 2 months

    Assessment of the ANS sympathetic branch thanks to SDNN index value

  3. Assessment of the ANS parasympathetic branch

    Time frame: Baseline to 2 months

    Assessment of the ANS parasympathetic branch thanks to RMSSSD index value

  4. non-invasive measurement of arterial stiffness

    Time frame: Baseline to 2 months

    value of pulse wave propagation velocity

  5. measurement of upper and lower limb muscle strength

    Time frame: Baseline to 2 months

    it's a composite outcome :

    • measurement of handgrip (kg) thanks to Jamar hydraulic hand dynamometer
    • measurement maximum quadriceps strength (kg) thanks to Contrex, Physiomed

  6. assessment of PFVP evolution

    Time frame: Baseline to 2 months

    assessment of PFVP evolution thaks to cycloergometer sprint (Monark, Vansbro)

  7. assessment of physical a activity and sedentary behavior

    Time frame: Baseline to 2 months

    it's a composite outcome :

    • assessment of physical a activity and sedentary behavior thanks to actimetry (Actigraph GT9x)
    • assessment of physical a activity and sedentary behavior thanks to Adult Physical Activity Questionnaire (APAQ)

  8. quality of life assessment

    Time frame: Baseline to 2 months

    it's a composite outcome :

    • with mental quality of life score
    • with physical quality of life score

  9. assessment of subjective fatigue

    Time frame: Baseline to 2 months

    assessment of subjective fatigue thanks to FACIT-F questionary

  10. biological data

    Time frame: Baseline to 2 months

    it's a composite outcome : complete blood biology and relevant inflammatory biomarkers involved in cardiac rehabilitation.

Study contacts

Contact information is provided by the study sponsor or research team.

David HUPIN, MD

CONTACT

[email protected]

(0)4 77 82 84 13 ext. +33

Hélène RAINGARD, CRA

CONTACT

[email protected]

(0)4.77.82.97.03 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability: A Controlled and Randomized Study

Acronym: PROPIU

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2023
Registry last updated
Jul 10, 2025

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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