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

No phase Interventional Acute Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: training strategy with adaptation of training strategies to the ANS, training strategy (standard practice).
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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
  • Other training strategy (standard practice)
    a training strategy for subjects whose PFVP is in favour of strength or speed

Primary outcome measures

  • The root mean square of successive differences in heart rate or RMSSD [Time frame: Baseline to 2 months]
Secondary outcome measures (10)
  • Value of maximum oxygen consumption [Time frame: Baseline to 2 months]
  • Assessment of the ANS sympathetic branch [Time frame: Baseline to 2 months]
  • Assessment of the ANS parasympathetic branch [Time frame: Baseline to 2 months]
  • non-invasive measurement of arterial stiffness [Time frame: Baseline to 2 months]
  • measurement of upper and lower limb muscle strength [Time frame: Baseline to 2 months]
  • assessment of PFVP evolution [Time frame: Baseline to 2 months]
  • assessment of physical a activity and sedentary behavior [Time frame: Baseline to 2 months]
  • quality of life assessment [Time frame: Baseline to 2 months]
  • assessment of subjective fatigue [Time frame: Baseline to 2 months]
  • biological data [Time frame: Baseline to 2 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Chu Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT06107452 · 23CH152 · 2023-A01452-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗