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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: training strategy with adaptation of training strategies to the ANS; Other: training strategy (standard practice)

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David HUPIN, MD; Phone Number: +33 (0)4 77 82 84 13; Email: david.hupin@chu-st-etienne.fr
• Study Contact Backup: Name: Hélène RAINGARD, CRA; Phone Number: +33 (0)4.77.82.97.03; Email: helene.raingard@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • Recruiting
    • CHU Saint-Etienne
    • Principal Investigator: David HUPIN, MD
    • Sub-Investigator: Frédéric ROCHE, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; a training strategy for subjects whose PFVP is in favour of strength or speed with training load adjusted according to SNA
Active Comparator: Control group; 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); a training strategy for subjects whose PFVP is in favour of strength or speed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: David HUPIN, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Coronary artery disease; Physical activity; Cardiac rehabilitation; Autonomic nervous system; Force-velocity profile
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: 23CH152; 2023-A01452-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No