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Completed

NCT Number: NCT04102410

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

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.

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sprints

Other

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.

Vertical jumps

Other

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.

Questionary Short Form-12 (SF-12)

Other

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

Device

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.

Other names: Wristlet connected

Program composed of two 2 training strategies

Other

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.

Program of usual practice

Other

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

Primary outcomes

  1. volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)

    Time frame: Months: 0 and 2

    Change in VO2 (volume of oxygen in ml/min/kg) at the first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).

Secondary outcomes

  1. VO2 max (volume of oxygen maximum in ml/min/kg)

    Time frame: Months: 0 and 2

    Comparison VO2 max (volume of oxygen maximum in ml/min/kg) during a Cardio-Pulmonary Exercise Test (CPET).

  2. Power at first ventilatory threshold (SV1)

    Time frame: Months: 0 and 2

    Comparison value of power at first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).

  3. Maximum aerobic power (in watt)

    Time frame: Months: 0 and 2

    Comparison maximum aerobic power (in watt) during a Cardio-Pulmonary Exercise Test (CPET).

  4. Voluntary muscle power (in kg) during a static muscle testing on quadriceps

    Time frame: Months: 0 and 2

    Comparison voluntary muscle power (in kg) during a static muscle testing on quadriceps.

  5. Voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps

    Time frame: Months: 0 and 2

    Comparison voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps.

  6. Value of muscular endurance (in min) during a static muscle testing on quadriceps

    Time frame: Months: 0 and 2

    Comparison value of muscular endurance (in min) during a static muscle testing on quadriceps.

  7. Value of muscular endurance (in min) during a dynamic muscle testing on quadriceps

    Time frame: Months: 0 and 2

    Comparison value of muscular endurance (in min) during a dynamic muscle testing on quadriceps.

  8. Standard Deviation of the Normal R-R interval (SDNN) index

    Time frame: Months: 0 and 2

    Measured by holter electrocardiogram during 24 hours.

  9. BaroReflex Sensitivity (BRS) (in ms/mmHg)

    Time frame: Months: 0 and 2

    Measured by baroreflex.

  10. Physical activity (in Metabolic Equivalent of Task (MET)-min/week)

    Time frame: Month: 0

    Assessment of Physical activity (in Metabolic Equivalent of Task (MET)-min/week).

    Measured by activity actigraph.

  11. Sedentary life (in hour/day)

    Time frame: Month: 0

    Assessment of Sedentary life (in hour/day). Measured by activity actigraph.

  12. SF-12 questionnaire score

    Time frame: Months: 0 and 2

    The 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Jean Monnet University

Registry information

Acronym: CITIUS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2019
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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