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

Acute Coronary Syndrome Clinical Trial

— PROPIU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107452
• Other study ID #: 23CH152
• Secondary ID: 2023-A01452-43
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: David HUPIN, MD
• Phone: (0)4 77 82 84 13
• Email: David.Hupin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Other:
• training strategy with adaptation of training strategies to the ANS
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)
a training strategy for subjects whose PFVP is in favour of strength or speed

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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