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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: Sprints; Other: Vertical jumps; Other: Questionary Short Form-12 (SF-12); Device: activity actigraph; Other: Program composed of two 2 training strategies; Other: Program of usual practice

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patient with acute coronary syndrome will be included. They will have sprints, vertical jumps, questionary Short Form-12 (SF-12), activity actigraph and program composed of two 2 training strategies.	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.; Other: 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.; Other: 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 Names: Wristlet connected; 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.
Sham Comparator: Control group; Patient with acute coronary syndrome will be included. They will have sprints, vertical jumps, questionary Short Form-12 (SF-12), activity actigraph and program of usual practice.	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.; Other: 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.; Other: 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 Names: Wristlet connected; Other: Program of usual practice; Program composed of training in force and speed independently of the initial Force/Velocity Profile (FVP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Maximum aerobic power (in watt)	Comparison maximum aerobic power (in watt) during a Cardio-Pulmonary Exercise Test (CPET).	Months: 0 and 2
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
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
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
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
Standard Deviation of the Normal R-R interval (SDNN) index	Measured by holter electrocardiogram during 24 hours.	Months: 0 and 2
BaroReflex Sensitivity (BRS) (in ms/mmHg)	Measured by baroreflex.	Months: 0 and 2
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
Sedentary life (in hour/day)	Assessment of Sedentary life (in hour/day). Measured by activity actigraph.	Month: 0
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Laboratoire SNA-EPIS - Université Jean Monnet

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): April 4, 2022
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; Physical activity; Cardiac rehabilitation; Autonomic nervous system; Force-velocity profile
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: 1708238; 2018-A01613-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No