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Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients

Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04102410
Acronym
CITIUS
Enrollment
120
Registered
2019-09-25
Start date
2019-09-30
Completion date
2022-04-04
Last updated
2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

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

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.

Interventions

OTHERSprints

Two sprints of 8 seconds on a cycle ergometer will be performed for determine Force/Velocity Profile (FVP). Realized at inclusion and 2 months after.

OTHERVertical jumps

Two vertical jumps will be performed. Height of theses vertical jumps will be measured by application My jump 2 to determine muscle power. Realized at inclusion and 2 months after.

OTHERQuestionary Short Form-12 (SF-12)

Questionary Short Form-12 (SF-12) will be performed to evaluate quality of life. It is composed of 12 questions. Realized at inclusion and 2 months after.

Activity actigraph will be wearing by patient during 7 consecutive days. It measures the level of physical activity and the sedentary lifestyle of patients. Realized at inclusion and 2 months after.

OTHERProgram composed of two 2 training strategies

Program composed of two 2 training strategies according to the initial Force/Velocity Profile (FVP) will be realized at the inclusion. There are : * Strategy experimental-speed: speed training strategy for subjects with a force-speed profile (PFV) in favour of force * Strategy experimental-force: force training strategy for subjects with a force-speed profile (PFV) in favour of speed.

OTHERProgram of usual practice

Program composed of training in force and speed independently of the initial Force/Velocity Profile (FVP).

Sponsors

Jean Monnet University
CollaboratorOTHER
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)Months: 0 and 2Change in VO2 (volume of oxygen in ml/min/kg) at the first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).

Secondary

MeasureTime frameDescription
Power at first ventilatory threshold (SV1)Months: 0 and 2Comparison value of power at first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).
Maximum aerobic power (in watt)Months: 0 and 2Comparison maximum aerobic power (in watt) during a Cardio-Pulmonary Exercise Test (CPET).
Voluntary muscle power (in kg) during a static muscle testing on quadricepsMonths: 0 and 2Comparison voluntary muscle power (in kg) during a static muscle testing on quadriceps.
Voluntary muscle power (in kg) during a dynamic muscle testing on quadricepsMonths: 0 and 2Comparison voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps.
Value of muscular endurance (in min) during a static muscle testing on quadricepsMonths: 0 and 2Comparison value of muscular endurance (in min) during a static muscle testing on quadriceps.
VO2 max (volume of oxygen maximum in ml/min/kg)Months: 0 and 2Comparison VO2 max (volume of oxygen maximum in ml/min/kg) during a Cardio-Pulmonary Exercise Test (CPET).
Standard Deviation of the Normal R-R interval (SDNN) indexMonths: 0 and 2Measured by holter electrocardiogram during 24 hours.
BaroReflex Sensitivity (BRS) (in ms/mmHg)Months: 0 and 2Measured by baroreflex.
Physical activity (in Metabolic Equivalent of Task (MET)-min/week)Month: 0Assessment of Physical activity (in Metabolic Equivalent of Task (MET)-min/week). Measured by activity actigraph.
Sedentary life (in hour/day)Month: 0Assessment of Sedentary life (in hour/day). Measured by activity actigraph.
SF-12 questionnaire scoreMonths: 0 and 2The SF-12 is a self-questionnaire to assess the quality of life. This tool is an abbreviated version of the Medical Outcomes Study Short-Form General Health Survey (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life).
Value of muscular endurance (in min) during a dynamic muscle testing on quadricepsMonths: 0 and 2Comparison value of muscular endurance (in min) during a dynamic muscle testing on quadriceps.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026