Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains (UTMB_2019)

December 13, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne

Acute physiological consequences of ultra-marathon running are still unknown, particularly in women. Some studies have suggested that the proportion of fatigue attributable to peripheral and central mechanisms varies between males and females; however, results are contradictory.

The results from the investigators of the present experiment in two studies conducted in 2009 and 2012 showed that:

  • A large part of fatigue induced by a mountain ultra-marathon could be attributed to central fatigue in males and that,
  • Females exhibited less peripheral fatigue in the plantar flexors than males did after a 110-km ultra-trail-running race.

According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running.

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

Thus, the main purpose of the present project is to investigate whether sex differences in neuromuscular fatigue in plantar flexors depend on the distance (> 100 km vs < 60 km).

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.
75

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
        • 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject listed in the race "2019 Mont Blanc Ultra Trail"
  • Affiliates or beneficiaries of social security scheme
  • Signed consent

Exclusion Criteria:

  • Subject having been injured in the previous 3 months
  • Pregnant woman
  • Chronic joint diseases
  • Chronic or central neurological pathologies
  • Taking neuroactive substances that can alter corticospinal excitability
  • Contraindication to experimental procedures including Transcranial Magnetic Stimulation (TMS)
  • Taking corticosteroids in the previous 3 months

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: Non-Randomized
  • Interventional Model: Parallel 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: female subjects involved in races over 100 km (F>100)
Female subjects involved in races over 100 km (F>100) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)
Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).
Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.
Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.
Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.
Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.
Experimental: female subjects involved in races less than 60 km (F<60)
Female subjects involved in races less than 60 km (F<60) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)
Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).
Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.
Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.
Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.
Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.
Experimental: male subjects involved in races over 100 km (H>100)
Male subjects involved in races over 100 km (H>100) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)
Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).
Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.
Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.
Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.
Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.
Experimental: male subjects involved in races less than 60 km (H<60)
Male subjects involved in races less than 60 km (H<60) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)
Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).
Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.
Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.
Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.
Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.

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
Variation (%) of the amplitudes of the electric shock
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by the electrically evoked force after contraction in isometric mode of the plantar flexors
5 or 6 day before the race and 1 hour after

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
Voluntary maximum forces plantar flexors
Time Frame: 5 or 6 day before the race and 1 hour after

Analysis :

  • Quantification of neuromuscular fatigue assessment;
  • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

Measured by voluntary maximum forces plantar flexors test (seat type Cybex) in percentage (%).
5 or 6 day before the race and 1 hour after
Voluntary maximum forces knee extensors
Time Frame: 5 or 6 day before the race and 1 hour after

Analysis :

  • Quantification of neuromuscular fatigue assessment;
  • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

Voluntary maximum forces knee extensors measures by seat type Cybex in percentage (%).
5 or 6 day before the race and 1 hour after
Electrically evoked forces
Time Frame: 5 or 6 day before the race and 1 hour after

Analysis :

  • Quantification of neuromuscular fatigue assessment;
  • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

Electrically evoked forces measures by neurostimulator in percentage (%).
5 or 6 day before the race and 1 hour after
ElectroMyoGraphic activity (EMG)
Time Frame: 5 or 6 day before the race and 1 hour after

Analysis :

  • Quantification of neuromuscular fatigue assessment;
  • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

ElectroMyoGraphic activity (EMG) measures by electromyography. The EMG signal will be recorded with pairs of electrodes fixed with an adhesive tape bilaterally over the muscular belly.
5 or 6 day before the race and 1 hour after
Three-Modality Evoked Potentials (TMEPs)
Time Frame: 5 or 6 day before the race and 1 hour after

Analysis :

  • Quantification of neuromuscular fatigue assessment;
  • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

Three-Modality Evoked Potentials (TMEPs) measures by magnetic stimulator in percentage (%).
5 or 6 day before the race and 1 hour after
Transcranial Magnetic Stimulation (TMS)
Time Frame: 5 or 6 day before the race and 1 hour after

Analysis :

  • Quantification of neuromuscular fatigue assessment;
  • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

Measured supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS) in percentage (%).
5 or 6 day before the race and 1 hour after
Force/Velocity Profile (FVP)
Time Frame: 5 or 6 day before the race and 1 hour after

Analysis:

  • Quantification of neuromuscular fatigue assessment;
  • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

Measured Force/Velocity Profile (FVP) test: 2 sprints of 8 seconds on a cycle ergometer.
5 or 6 day before the race and 1 hour after
Blood viscosity
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
Number of red blood cell
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
Number of platelets
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
Number of white blood cells
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
Rate of hemoglobin (%)
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
creatinine (mg/L)
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
C reactive protein (CRP) (mg/L)
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
urea (g/L)
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
uric acid (mg/L)
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
lactate (mg/L)
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by blood sample.
5 or 6 day before the race and 1 hour after
Proteinuria-density urinary (mg/24h)
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by urinary sample.
5 or 6 day before the race and 1 hour after
Kinematic variable
Time Frame: 5 or 6 day before the race and 1 hour after
Measured by treadmill result.
5 or 6 day before the race and 1 hour after

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, University of Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 2, 2019

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.
September 1, 2019

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.
September 1, 2019

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 3, 2019

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.
July 17, 2019

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.
July 18, 2019

Study Record Updates

Last Update Posted (Estimate)

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.
December 15, 2022

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.
December 13, 2022

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.
December 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.
  • 19CH060
  • 2019-A00736-51 (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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