Acute Coronary Syndrome Clinical Trial
— PROPIUOfficial title:
Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability: A Controlled and Randomized Study
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
Status | Recruiting |
Enrollment | 110 |
Est. completion date | February 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Saint-Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Value of maximum oxygen consumption | VO2 max (ml/min/kg) thanks to 24-hour ECG recording | Baseline to 2 months | |
Secondary | Assessment of the ANS sympathetic branch | Assessment of the ANS sympathetic branch thanks to SDNN index value | Baseline to 2 months | |
Secondary | Assessment of the ANS parasympathetic branch | Assessment of the ANS parasympathetic branch thanks to RMSSSD index value | Baseline to 2 months | |
Secondary | non-invasive measurement of arterial stiffness | value of pulse wave propagation velocity | Baseline to 2 months | |
Secondary | 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 | |
Secondary | assessment of PFVP evolution | assessment of PFVP evolution thaks to cycloergometer sprint (Monark, Vansbro) | Baseline to 2 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | assessment of subjective fatigue | assessment of subjective fatigue thanks to FACIT-F questionary | Baseline to 2 months | |
Secondary | biological data | it's a composite outcome : complete blood biology and relevant inflammatory biomarkers involved in cardiac rehabilitation. | Baseline to 2 months |
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