Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients (CITIUS)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sprints
Vertical jumps
Questionary Short Form-12 (SF-12)
activity actigraph
Program composed of two 2 training strategies
Program of usual practice
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring Cardiac rehabilitation, Physical activity, Force-velocity profile, Autonomic nervous system, Coronary artery disease
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
Sites / Locations
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Power at first ventilatory threshold (SV1)
Comparison value of power at first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).
Maximum aerobic power (in watt)
Comparison maximum aerobic power (in watt) during a Cardio-Pulmonary Exercise Test (CPET).
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.
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.
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.
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.
Standard Deviation of the Normal R-R interval (SDNN) index
Measured by holter electrocardiogram during 24 hours.
BaroReflex Sensitivity (BRS) (in ms/mmHg)
Measured by baroreflex.
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.
Sedentary life (in hour/day)
Assessment of Sedentary life (in hour/day). Measured by activity actigraph.
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).
Full Information
NCT ID
NCT04102410
First Posted
September 23, 2019
Last Updated
June 2, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire SNA-EPIS - Université Jean Monnet
1. Study Identification
Unique Protocol Identification Number
NCT04102410
Brief Title
Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
Acronym
CITIUS
Official Title
Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire SNA-EPIS - Université Jean Monnet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Cardiac rehabilitation, Physical activity, Force-velocity profile, Autonomic nervous system, Coronary artery disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sprints
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vertical jumps
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionary Short Form-12 (SF-12)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
activity actigraph
Other Intervention Name(s)
Wristlet connected
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Program composed of two 2 training strategies
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Program of usual practice
Intervention Description
Program composed of training in force and speed independently of the initial Force/Velocity Profile (FVP).
Primary Outcome Measure Information:
Title
volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)
Description
Change in VO2 (volume of oxygen in ml/min/kg) at the first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).
Time Frame
Months: 0 and 2
Secondary Outcome Measure Information:
Title
VO2 max (volume of oxygen maximum in ml/min/kg)
Description
Comparison VO2 max (volume of oxygen maximum in ml/min/kg) during a Cardio-Pulmonary Exercise Test (CPET).
Time Frame
Months: 0 and 2
Title
Power at first ventilatory threshold (SV1)
Description
Comparison value of power at first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).
Time Frame
Months: 0 and 2
Title
Maximum aerobic power (in watt)
Description
Comparison maximum aerobic power (in watt) during a Cardio-Pulmonary Exercise Test (CPET).
Time Frame
Months: 0 and 2
Title
Voluntary muscle power (in kg) during a static muscle testing on quadriceps
Description
Comparison voluntary muscle power (in kg) during a static muscle testing on quadriceps.
Time Frame
Months: 0 and 2
Title
Voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps
Description
Comparison voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps.
Time Frame
Months: 0 and 2
Title
Value of muscular endurance (in min) during a static muscle testing on quadriceps
Description
Comparison value of muscular endurance (in min) during a static muscle testing on quadriceps.
Time Frame
Months: 0 and 2
Title
Value of muscular endurance (in min) during a dynamic muscle testing on quadriceps
Description
Comparison value of muscular endurance (in min) during a dynamic muscle testing on quadriceps.
Time Frame
Months: 0 and 2
Title
Standard Deviation of the Normal R-R interval (SDNN) index
Description
Measured by holter electrocardiogram during 24 hours.
Time Frame
Months: 0 and 2
Title
BaroReflex Sensitivity (BRS) (in ms/mmHg)
Description
Measured by baroreflex.
Time Frame
Months: 0 and 2
Title
Physical activity (in Metabolic Equivalent of Task (MET)-min/week)
Description
Assessment of Physical activity (in Metabolic Equivalent of Task (MET)-min/week).
Measured by activity actigraph.
Time Frame
Month: 0
Title
Sedentary life (in hour/day)
Description
Assessment of Sedentary life (in hour/day). Measured by activity actigraph.
Time Frame
Month: 0
Title
SF-12 questionnaire score
Description
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).
Time Frame
Months: 0 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
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