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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Other: training strategy with adaptation of training strategies to the ANS
* Other: training strategy (standard practice)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patient with acute coronary syndrome will be included. According to their initial strength-speed profile, coronary patients will benefit from an individualized cardiac rehabilitation program, with strength or speed training adapted to the autonomic nervous system (ANS). | Other: training strategy with adaptation of training strategies to the ANS<br>* a training strategy for subjects whose PFVP is in favour of strength or speed with training load adjusted according to SNA<br>|
| Active Comparator: Control group<br>Patient with acute coronary syndrome will be included. According to their initial force-velocity profile, coronary patients will have an individualized cardiac rehabilitation program, either with a training in force or in velocity. | Other: training strategy (standard practice)<br>* a training strategy for subjects whose PFVP is in favour of strength or speed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The root mean square of successive differences in heart rate or RMSSD | 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. | Baseline to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of maximum oxygen consumption | VO2 max (ml/min/kg) thanks to 24-hour ECG recording | Baseline to 2 months | 
| Assessment of the ANS sympathetic branch | Assessment of the ANS sympathetic branch thanks to SDNN index value | Baseline to 2 months | 
| Assessment of the ANS parasympathetic branch | Assessment of the ANS parasympathetic branch thanks to RMSSSD index value | Baseline to 2 months | 
| non-invasive measurement of arterial stiffness | value of pulse wave propagation velocity | Baseline to 2 months | 
| measurement of upper and lower limb muscle strength | it's a composite outcome : measurement of handgrip (kg) thanks to Jamar hydraulic hand dynamometer measurement maximum quadriceps strength (kg) thanks to Contrex, Physiomed | Baseline to 2 months | 
| assessment of PFVP evolution | assessment of PFVP evolution thaks to cycloergometer sprint (Monark, Vansbro) | Baseline to 2 months | 
| assessment of physical a activity and sedentary behavior | 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) | Baseline to 2 months | 
| quality of life assessment | it's a composite outcome : with mental quality of life score with physical quality of life score | Baseline to 2 months | 
| assessment of subjective fatigue | assessment of subjective fatigue thanks to FACIT-F questionary | Baseline to 2 months | 
| biological data | it's a composite outcome : complete blood biology and relevant inflammatory biomarkers involved in cardiac rehabilitation. | Baseline to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac rehabilitation, Physical activity, Force-velocity profile, Autonomic nervous system, Coronary artery disease