Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling (FAT-CENTR)

November 23, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne
The mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. Ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. This protocol will compare fatigue during and after ultra-endurance exercise bouts that result in moderate lower-limb tissue damage (i.e. cycling) or significant damage (i.e. running). The results of this protocol will allow us to further understanding of the reasons for major central fatigue, i.e. within the central nervous system, in ultra-endurance.

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.

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.
19

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 Locations

  • France
      • Saint-Étienne, France, 42000
        • CHU 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Specialist in endurance and ultra-endurance. in the 2 disciplines: running and cycling (triathletes, duathletes or trailers achieving at least 30% of their training volume in cycling), and having at least finished one long distance event in the last 2 years,
  • Affiliated or beneficiary of a social security scheme.
  • Signature of the consent form

Exclusion Criteria:

  • Any subject who has been injured in the 3 months prior to the protocol
  • Anyone with chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems).
  • Any subject with chronic or central neurological pathologies
  • Any subject with a contraindication to magnetic stimulation
  • Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) on the study.

  • Contraindication to the application of a magnetic field:

    • Heart or respiratory insufficiency.
    • Subject with a cardiac pace maker.
    • Cardiac valve wear and serious cardiovascular diseases.
    • Presence of prosthetic material or ferromagnetic foreign bodies in the head.
    • Presence of cochlear implants or ocular prosthetic material.
    • History of neurosurgical interventions.
    • Neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumour, multiple sclerosis, history of stroke or traumatic brain injury).
    • History of comitiality, contralateral knee disease or musculoskeletal disease.
  • Any subject participating at the same time in another interventional experiment requiring physical exercise.
  • Any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).
  • Any subject under guardianship or curatorship

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover 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.
Experimental: Running endurance
Athletes wiil run for 5 hours in a row.
Other: maximum effort test on a treadmill
5 h test on treadmill
Experimental: Cycling endurance
Athletes wiil cycle for 5 hours in a row.
Other: maximum effort test on a cycloergometer
5 h test on cycloergometer

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
Maximum level of voluntary activation of relative central fatigue
Time Frame: Before and immediately after 5h exercise
measured in isometric mode of the knee extensors, between the value before and immediately after a 5-hour cycling or running event at the same relative intensity
Before and immediately after 5h exercise

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 level of voluntary activation of fatigue centrale absolute
Time Frame: Before and immediately after 5h exercise
measured in isometric mode of the knee extensors, between the value before the 5h cycling or running and the value after absolute exhaustion
Before and immediately after 5h exercise
Maximum level of voluntary activation with electrical evoked activation
Time Frame: Before and immediately after 5h exercise
tests with measurement of the maximum voluntary with evoked electrical between the value before and immediately after a 5-hour cycling or running event at the same relative intensity
Before and immediately after 5h exercise
Spinal excitability
Time Frame: Before and immediately after 5h exercise
thoracic spine stimulation for the recording of thoracic motor evoked potentials
Before and immediately after 5h exercise
Corticospinal excitability
Time Frame: Before and immediately after 5h exercise
stimulation of the motor cortex for recording motor evoked potentials
Before and immediately after 5h exercise
Cortical excitability
Time Frame: Before and immediately after 5h exercise
ratio between stimulation of the motor cortex and thoracic spine stimulation
Before and immediately after 5h exercise
Measurement of isometric force values
Time Frame: Before and immediately after 5h exercise
subjects sitting on a Cybex type seat, with the knee and hip angle set at 90°. The foot will be attached to a strain-gauge sensor using a velcro strap attached to the ankle above the medial malleolus.
Before and immediately after 5h exercise
Measurement of speed, force and power values
Time Frame: Before and immediately after 5h exercise
assessment of fatigue in dynamic mode (calculation of the force/speed profile)
Before and immediately after 5h exercise
Red blood cells
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
Platelets
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
White blood cells
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
Hemoglobin
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
Mean corpuscular hemoglobin concentration
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
C-reactive protein
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
Creatine PhosphoKinase
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
Interleukines
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
Lactate
Time Frame: Before and immediately after 5h exercise
blood sample
Before and immediately after 5h exercise
Measurement of the time maintained at the speed corresponding to the 2nd ventilatory threshold
Time Frame: Before and immediately after 5h exercise
On treadmill
Before and immediately after 5h exercise
measurement of the time maintained at the power corresponding to the 2nd ventilatory threshold
Time Frame: Before and immediately after 5h exercise
On Cycloergometer
Before and immediately after 5h exercise

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.
  • Study Director: Guillaume MILLET, PhD, Saint-Etienne University

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.
March 5, 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.
May 28, 2021

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.
July 15, 2021

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).
July 31, 2020

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 11, 2020

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 13, 2020

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.
November 24, 2021

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.
November 23, 2021

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.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 19CH217
  • 2020-A01714-35 (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

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.

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