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Completed

NCT Number: NCT04025138

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

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.

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Key information

Conditions

Ultra-marathon Runners

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular tests in isometric mode

Other

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)

Transcranial Magnetic Stimulation (TMS)

Device

Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).

Neuromuscular fatigue assessment test

Other

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.

treadmill

Other

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.

Blood sample

Biological

Blood sample will be realized to measure hemorrheologic and hematologic parameters.

Urinary sample

Biological

Urinary sample will be realized to measure hemorrheologic and hematologic parameters.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 (%).

  2. 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 (%).

  3. 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 (%).

  4. 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. 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 (%).

  6. 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 (%).

  7. 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.

  8. Blood viscosity

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  9. Number of red blood cell

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  10. Number of platelets

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  11. Number of white blood cells

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  12. Rate of hemoglobin (%)

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  13. creatinine (mg/L)

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  14. C reactive protein (CRP) (mg/L)

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  15. urea (g/L)

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  16. uric acid (mg/L)

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  17. lactate (mg/L)

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by blood sample.

  18. Proteinuria-density urinary (mg/24h)

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by urinary sample.

  19. Kinematic variable

    Time frame: 5 or 6 day before the race and 1 hour after

    Measured by treadmill result.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: UTMB_2019

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2019
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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