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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06107452

Collaborator

(none)

110

Enrollment

Location

Arms

15.1

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Other: training strategy with adaptation of training strategies to the ANS Other: training strategy (standard practice)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The root mean square of successive differences in heart rate or RMSSD [Baseline to 2 months]
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.

Secondary Outcome Measures

Value of maximum oxygen consumption [Baseline to 2 months]
VO2 max (ml/min/kg) thanks to 24-hour ECG recording
Assessment of the ANS sympathetic branch [Baseline to 2 months]
Assessment of the ANS sympathetic branch thanks to SDNN index value
Assessment of the ANS parasympathetic branch [Baseline to 2 months]
Assessment of the ANS parasympathetic branch thanks to RMSSSD index value
non-invasive measurement of arterial stiffness [Baseline to 2 months]
value of pulse wave propagation velocity
measurement of upper and lower limb muscle strength [Baseline to 2 months]
it's a composite outcome : measurement of handgrip (kg) thanks to Jamar hydraulic hand dynamometer measurement maximum quadriceps strength (kg) thanks to Contrex, Physiomed
assessment of PFVP evolution [Baseline to 2 months]
assessment of PFVP evolution thaks to cycloergometer sprint (Monark, Vansbro)
assessment of physical a activity and sedentary behavior [Baseline to 2 months]
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)
quality of life assessment [Baseline to 2 months]
it's a composite outcome : with mental quality of life score with physical quality of life score
assessment of subjective fatigue [Baseline to 2 months]
assessment of subjective fatigue thanks to FACIT-F questionary
biological data [Baseline to 2 months]
it's a composite outcome : complete blood biology and relevant inflammatory biomarkers involved in cardiac rehabilitation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: David HUPIN, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT06107452

Other Study ID Numbers:

23CH152
2023-A01452-43

First Posted:

Oct 30, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Cardiac rehabilitation

Physical activity

Force-velocity profile

Autonomic nervous system

Coronary artery disease

Additional relevant MeSH terms:

Acute Coronary Syndrome

Study Results

No Results Posted as of Oct 30, 2023