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

NCT ID: NCT04102410

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-04-04

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sprints

Intervention Type 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

Intervention Type 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)

Intervention Type 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

Intervention Type 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.

Program composed of two 2 training strategies

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Sprints

Intervention Type 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

Intervention Type 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)

Intervention Type 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

Intervention Type 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.

Program of usual practice

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Program of usual practice

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

Intervention Type OTHER

Other Intervention Names

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Wristlet connected

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jean Monnet University

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2018-A01613-52

Identifier Type: OTHER

Identifier Source: secondary_id

1708238

Identifier Type: -

Identifier Source: org_study_id

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