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

NCT ID: NCT06107452

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2026-05-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

training strategy with adaptation of training strategies to the ANS

Intervention Type: OTHER

a training strategy for subjects whose PFVP is in favour of strength or speed with training load adjusted according to SNA

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.

Group Type: ACTIVE_COMPARATOR

training strategy (standard practice)

Intervention Type: OTHER

a training strategy for subjects whose PFVP is in favour of strength or speed

Interventions

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

Intervention Type: OTHER

training strategy (standard practice)

a training strategy for subjects whose PFVP is in favour of strength or speed

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David HUPIN, MD

Role: CONTACT

David.Hupin@chu-st-etienne.fr

(0)4 77 82 84 13 ext. +33

Hélène RAINGARD, CRA

Role: CONTACT

helene.raingard@chu-st-etienne.fr

(0)4.77.82.97.03 ext. +33

Other Identifiers

2023-A01452-43

Identifier Type: OTHER

Identifier Source: secondary_id

23CH152

Identifier Type: -

Identifier Source: org_study_id