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

Acute Coronary Syndrome Clinical Trial

— CITIUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102410
• Other study ID #: 1708238
• Secondary ID: 2018-A01613-52
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: April 4, 2022

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Other:
• Sprints
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
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)
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.

Device:
• activity actigraph
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:
• Program 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.
• Program of usual practice
Program composed of training in force and speed independently of the initial Force/Velocity Profile (FVP).

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Laboratoire SNA-EPIS - Université Jean Monnet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)	Change in VO2 (volume of oxygen in ml/min/kg) at the first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).	Months: 0 and 2
Secondary	VO2 max (volume of oxygen maximum in ml/min/kg)	Comparison VO2 max (volume of oxygen maximum in ml/min/kg) during a Cardio-Pulmonary Exercise Test (CPET).	Months: 0 and 2
Secondary	Power at first ventilatory threshold (SV1)	Comparison value of power at first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).	Months: 0 and 2
Secondary	Maximum aerobic power (in watt)	Comparison maximum aerobic power (in watt) during a Cardio-Pulmonary Exercise Test (CPET).	Months: 0 and 2
Secondary	Voluntary muscle power (in kg) during a static muscle testing on quadriceps	Comparison voluntary muscle power (in kg) during a static muscle testing on quadriceps.	Months: 0 and 2
Secondary	Voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps	Comparison voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps.	Months: 0 and 2
Secondary	Value of muscular endurance (in min) during a static muscle testing on quadriceps	Comparison value of muscular endurance (in min) during a static muscle testing on quadriceps.	Months: 0 and 2
Secondary	Value of muscular endurance (in min) during a dynamic muscle testing on quadriceps	Comparison value of muscular endurance (in min) during a dynamic muscle testing on quadriceps.	Months: 0 and 2
Secondary	Standard Deviation of the Normal R-R interval (SDNN) index	Measured by holter electrocardiogram during 24 hours.	Months: 0 and 2
Secondary	BaroReflex Sensitivity (BRS) (in ms/mmHg)	Measured by baroreflex.	Months: 0 and 2
Secondary	Physical activity (in Metabolic Equivalent of Task (MET)-min/week)	Assessment of Physical activity (in Metabolic Equivalent of Task (MET)-min/week).; Measured by activity actigraph.	Month: 0
Secondary	Sedentary life (in hour/day)	Assessment of Sedentary life (in hour/day). Measured by activity actigraph.	Month: 0
Secondary	SF-12 questionnaire score	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).	Months: 0 and 2