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

NCT06107452 | Recruiting

• 2 other identifiers: 23CH1522023-A01452-43
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Coronary Syndrome

Keywords

Cardiac rehabilitation; Physical activity; Force-velocity profile; Autonomic nervous system; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Value of maximum oxygen consumption

  Baseline to 2 months

• Assessment of the ANS sympathetic branch

  Baseline to 2 months

• Assessment of the ANS parasympathetic branch

  Baseline to 2 months

• non-invasive measurement of arterial stiffness

  Baseline to 2 months

• measurement of upper and lower limb muscle strength

  Baseline to 2 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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)

Interventions

training strategy with adaptation of training strategies to the ANS OTHER

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

Experimental group

training strategy (standard practice) OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• \- Significant co-morbidities limited practice of physical activity

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Motor Activity; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• David HUPIN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David HUPIN, MD

CONTACT

(0)4 77 82 84 13; David.Hupin@chu-st-etienne.fr

Hélène RAINGARD, CRA

CONTACT

(0)4.77.82.97.03; helene.raingard@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 30, 2023
• Study Start: February 5, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)