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

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Other: training strategy (standard practice); Other: training strategy with adaptation of training strategies to the ANS

• Registration Number: NCT06107452
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-10-30
• Study Start: 2024-02-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	training strategy (standard practice)	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.
Experimental group	training strategy with adaptation of training strategies to the ANS	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).

Primary Outcome Measures

Name	Time	Method
The root mean square of successive differences in heart rate or RMSSD	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 Outcome Measures

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

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France