Clinical trial NCT04102410: Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
Official title: Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Cardiac rehabilitation
Physical activity
Force-velocity profile
Autonomic nervous system
Coronary artery disease
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Jean Monnet University
First posted: 2019-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cardiac rehabilitation includes aerobic and anaerobic training adapted to cardiovascular pathology for which cardiac rehabilitation is prescribed. It is essential to adapt the content of these cardiac rehabilitation sessions to optimize aerobic and anaerobic performance and quality of life. Improvement of the first ventilatory threshold is one of the main objectives since it illustrates the adaptation of the patient to submaximal exercise, typical of everyday life.

The research laboratory "Autonomous Nervous System - Epidemiology, Physiology, Engineering, Health" (SPA-EPIS) has an international expertise in training optimization in top-athletes. He have shown the importance of the relationship between the power-force-velocity profile and athletes performances.

Detailed description: In this sudy, each patient has a force and a velocity that can be optimized with training to achieve maximum power. This optimization can be evaluated through a force-velocity profile, measured from an only sprint on a cycloergometer.

The hypothesis that force-velocity profile could be used in cardiac rehabilitation in coronary patients to induce a force-velocity balance adapted through personalized sessions and regular medical follow-up.

This prospective, controlled, randomized and open label study will attempt to evaluate further the relevance of force or velocity training based on the initial force-velocity profile of coronary patients included in the cardiac rehabilitation program in the University Hospital of Saint-Etienne.

Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome treated within the last 6 months
* Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
* During initial effort test: Maximum aerobic power≥ 60 watts for women and ≥ 80 watts for men
* Patient affiliated or beneficiary to social security
* Signed informed consent

Exclusion Criteria:

* Significant co-morbidities limited practice of physical activity
* Inability to submit to medical monitoring of the program
* Patient deprived of liberty or patient under guardianship
* Pregnant woman

Primary outcomes:
measure: volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)
timeFrame: Months: 0 and 2
Secondary outcomes:
measure: VO2 max (volume of oxygen maximum in ml/min/kg)
timeFrame: Months: 0 and 2
measure: Power at first ventilatory threshold (SV1)
timeFrame: Months: 0 and 2
measure: Maximum aerobic power (in watt)
timeFrame: Months: 0 and 2
measure: Voluntary muscle power (in kg) during a static muscle testing on quadriceps
timeFrame: Months: 0 and 2
measure: Voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps
timeFrame: Months: 0 and 2
measure: Value of muscular endurance (in min) during a static muscle testing on quadriceps
timeFrame: Months: 0 and 2
measure: Value of muscular endurance (in min) during a dynamic muscle testing on quadriceps
timeFrame: Months: 0 and 2
measure: Standard Deviation of the Normal R-R interval (SDNN) index
timeFrame: Months: 0 and 2
measure: BaroReflex Sensitivity (BRS) (in ms/mmHg)
timeFrame: Months: 0 and 2
measure: Physical activity (in Metabolic Equivalent of Task (MET)-min/week)
timeFrame: Month: 0
measure: Sedentary life (in hour/day)
timeFrame: Month: 0
measure: SF-12 questionnaire score
timeFrame: Months: 0 and 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References: