Sprint Interval Training on the Endurance, Strength and Velocity Capacities of Healthy Sedentary Subjects (BénéfiSIT)

July 18, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Sprint Interval Training (SIT) on the Endurance, Strength and Velocity Capacities of Healthy Sedentary Subjects

The present study aims to analyse first, the acute effects generated by a single bout of Sprint Interval Training (SIT) and, secondly, the effects of a long-term intervention on sedentary participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main goal is to determine the optimal dose of high-intensity exercise that enhances the best physiological adaptations.

The cumulative effects of SIT, will be assessed by a series of measures placed throughout the time-course (before, after the 1st , the 2nd and the 3rd block of SIT). Those measures consist of physiological measurements (VO2max), neuromuscular capacities (force-velocity profile) the autonomic nervous system responses (heart rate variability) and blood markers (lactate, Creatine phosphoKinase (CK), cytokinases, µRNA). Acute effects will be measured in the familiarisation sessions (after short (8 sprints) and long (14 sprints) sets) by performing a battery of neuromuscular, perceptual, and autonomic nervous system tests before and after the single session of SIT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • untrained healthy (less than 2 hours of sport per week)
  • free from muscular, bone or joint injuries
  • free from neurologic disease

Exclusion Criteria:

  • taking neuroactive substances that can alter corticospinal excitability
  • Heart or respiratory failure.
  • Subjects who have taken corticosteroids within 3 months (inhalation, infiltration or history of corticosteroid therapy).
  • Pregnant woman
  • Subject under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Sedentary participants

Series of measures placed throughout the time-course (before, after the 1st , the 2nd and the 3rd block of SIT).

These measurements consist of physiological measurements (VO2max), neuromuscular capacities (force-speed profile), autonomic nervous system responses (heart rate variability) and blood markers (lactate, CK, cytokinases, µRNA).
Other: Sprint Interval Training

The Sprint Interval Training (SIT) training consists of 3 successive blocks of 5 training sessions each. The sessions are 24 to 48 hours apart.

. One block lasts two weeks. After the end of one block, the following block begins the day after.

The Sprint Interval Training lasts 6 weeks.

Each session consists of a series of sprints, the number of which varies from 8 to 14. Thus a session will last from 30 to 45 min approximately

So, the time frame of this study is Baseline, Block 1, Block 2 and Block 3 (Not in day or week or month)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
oxygen uptake (VO2max) - ml/min/kg
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart

consumption oxygen uptake (VO2max) measured on a cycle ergometer

The main objective is to determine at which time frame of sprint interval training blocks, the endurance performance (VO2max) is best.
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum power (W)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
It is measured thanks to the force-speed profile using two sprints of 7s with braking forces of 0 , 4 and 0.7 N.kg-1 respectively.
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Maximum theoretical force (N.m)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
It is measured thanks to the force-speed profile using two sprints of 7s with braking forces of 0 , 4 and 0.7 N.kg-1 respectively.
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Maximum theoretical speed (m/s)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
It is measured thanks to the force-speed profile using two sprints of 7s with braking forces of 0 , 4 and 0.7 N.kg-1 respectively.
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Maximum isometric force (N.m)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
It is measured by means of a voluntary maximum contraction test in which the maximum force generated voluntarily is compared to that voluntarily generated force will be compared to that evoked using electrical stimulation of the femoral nerve.
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
heart rate variability (HRV)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Lactate (mmol/l)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Blood sample
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Cytokines (pg/ml)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Blood sample
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Creatine Kinase (UI/l)
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Blood sample
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
muscle microRNA
Time Frame: At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart
Blood sample
At the end of the 1st, 2nd and 3rd block : Each block = 2 weeks; each block is 1 day apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leonard FEASSON, MD-PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20CH238
  • ANSM (Other Identifier: 2024-A02435-42)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings