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

Not Applicable

Completed

• Conditions: Ultra-marathon Runners
• Interventions: Other: Neuromuscular tests in isometric mode; Device: Transcranial Magnetic Stimulation (TMS); Other: Neuromuscular fatigue assessment test; Other: treadmill; Biological: Blood sample; Biological: Urinary sample

• Registration Number: NCT04025138
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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 Timeline

• Study Start: 2019-07-02
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
female subjects involved in races less than 60 km (F<60)	Neuromuscular tests in isometric mode	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.
male subjects involved in races over 100 km (H>100)	Neuromuscular fatigue assessment test	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.
male subjects involved in races over 100 km (H>100)	Urinary sample	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.
male subjects involved in races less than 60 km (H<60)	treadmill	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.
male subjects involved in races less than 60 km (H<60)	Blood sample	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.
female subjects involved in races over 100 km (F>100)	treadmill	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.
female subjects involved in races less than 60 km (F<60)	Blood sample	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.
female subjects involved in races over 100 km (F>100)	Neuromuscular fatigue assessment test	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.
male subjects involved in races over 100 km (H>100)	Neuromuscular tests in isometric mode	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.
male subjects involved in races over 100 km (H>100)	Transcranial Magnetic Stimulation (TMS)	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.
female subjects involved in races over 100 km (F>100)	Urinary sample	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.
female subjects involved in races less than 60 km (F<60)	treadmill	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.
male subjects involved in races over 100 km (H>100)	Blood sample	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.
male subjects involved in races less than 60 km (H<60)	Neuromuscular tests in isometric mode	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.
male subjects involved in races less than 60 km (H<60)	Neuromuscular fatigue assessment test	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.
female subjects involved in races over 100 km (F>100)	Transcranial Magnetic Stimulation (TMS)	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.
female subjects involved in races over 100 km (F>100)	Blood sample	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.
female subjects involved in races less than 60 km (F<60)	Transcranial Magnetic Stimulation (TMS)	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.
female subjects involved in races less than 60 km (F<60)	Urinary sample	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.
male subjects involved in races over 100 km (H>100)	treadmill	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.
male subjects involved in races less than 60 km (H<60)	Transcranial Magnetic Stimulation (TMS)	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.
male subjects involved in races less than 60 km (H<60)	Urinary sample	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.
female subjects involved in races over 100 km (F>100)	Neuromuscular tests in isometric mode	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.
female subjects involved in races less than 60 km (F<60)	Neuromuscular fatigue assessment test	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.

Primary Outcome Measures

Name	Time	Method
Variation (%) of the amplitudes of the electric shock	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 Outcome Measures

Name	Time	Method
C reactive protein (CRP) (mg/L)	5 or 6 day before the race and 1 hour after	Measured by blood sample.
Blood viscosity	5 or 6 day before the race and 1 hour after	Measured by blood sample.
urea (g/L)	5 or 6 day before the race and 1 hour after	Measured by blood sample.
Electrically evoked forces	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 (%).
Voluntary maximum forces plantar flexors	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 (%).
Voluntary maximum forces knee extensors	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 (%).
Three-Modality Evoked Potentials (TMEPs)	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 (%).
Force/Velocity Profile (FVP)	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.
ElectroMyoGraphic activity (EMG)	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.
Number of red blood cell	5 or 6 day before the race and 1 hour after	Measured by blood sample.
Transcranial Magnetic Stimulation (TMS)	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 (%).
Number of platelets	5 or 6 day before the race and 1 hour after	Measured by blood sample.
Rate of hemoglobin (%)	5 or 6 day before the race and 1 hour after	Measured by blood sample.
creatinine (mg/L)	5 or 6 day before the race and 1 hour after	Measured by blood sample.
Number of white blood cells	5 or 6 day before the race and 1 hour after	Measured by blood sample.
uric acid (mg/L)	5 or 6 day before the race and 1 hour after	Measured by blood sample.
lactate (mg/L)	5 or 6 day before the race and 1 hour after	Measured by blood sample.
Kinematic variable	5 or 6 day before the race and 1 hour after	Measured by treadmill result.
Proteinuria-density urinary (mg/24h)	5 or 6 day before the race and 1 hour after	Measured by urinary sample.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France