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

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

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: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Variation (%) of the amplitudes of the electric shock	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

Outcome Measure	Measure Description	Time Frame
Voluntary maximum forces plantar flexors	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	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	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)	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)	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)	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)	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	Measured by blood sample.	5 or 6 day before the race and 1 hour after
Number of red blood cell	Measured by blood sample.	5 or 6 day before the race and 1 hour after
Number of platelets	Measured by blood sample.	5 or 6 day before the race and 1 hour after
Number of white blood cells	Measured by blood sample.	5 or 6 day before the race and 1 hour after
Rate of hemoglobin (%)	Measured by blood sample.	5 or 6 day before the race and 1 hour after
creatinine (mg/L)	Measured by blood sample.	5 or 6 day before the race and 1 hour after
C reactive protein (CRP) (mg/L)	Measured by blood sample.	5 or 6 day before the race and 1 hour after
urea (g/L)	Measured by blood sample.	5 or 6 day before the race and 1 hour after
uric acid (mg/L)	Measured by blood sample.	5 or 6 day before the race and 1 hour after
lactate (mg/L)	Measured by blood sample.	5 or 6 day before the race and 1 hour after
Proteinuria-density urinary (mg/24h)	Measured by urinary sample.	5 or 6 day before the race and 1 hour after
Kinematic variable	Measured by treadmill result.	5 or 6 day before the race and 1 hour after

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Study Director: Guillaume MILLET, PhD, University of Saint-Etienne

Publications and helpful links

General Publications

• Robert M, Stauffer E, Nader E, Skinner S, Boisson C, Cibiel A, Feasson L, Renoux C, Robach P, Joly P, Millet GY, Connes P. Impact of Trail Running Races on Blood Viscosity and Its Determinants: Effects of Distance. Int J Mol Sci. 2020 Nov 12;21(22):8531. doi: 10.3390/ijms21228531.
• Temesi J, Besson T, Parent A, Singh B, Martin V, Brownstein CG, Espeit L, Royer N, Rimaud D, Lapole T, Feasson L, Millet GY. Effect of race distance on performance fatigability in male trail and ultra-trail runners. Scand J Med Sci Sports. 2021 Sep;31(9):1809-1821. doi: 10.1111/sms.14004. Epub 2021 Jul 12.
• Foure A, Besson T, Stauffer E, Skinner SC, Bouvier J, Feasson L, Connes P, Hautier CA, Millet GY. Sex-related differences and effects of short and long trail running races on resting muscle-tendon mechanical properties. Scand J Med Sci Sports. 2022 Oct;32(10):1477-1492. doi: 10.1111/sms.14203. Epub 2022 Jul 6.
• Pastor FS, Besson T, Varesco G, Parent A, Fanget M, Koral J, Foschia C, Rupp T, Rimaud D, Feasson L, Millet GY. Performance Determinants in Trail-Running Races of Different Distances. Int J Sports Physiol Perform. 2022 Jun 1;17(6):844-851. doi: 10.1123/ijspp.2021-0362. Epub 2022 Feb 25.
• Sabater Pastor F, Varesco G, Besson T, Koral J, Feasson L, Millet GY. Degradation of energy cost with fatigue induced by trail running: effect of distance. Eur J Appl Physiol. 2021 Jun;121(6):1665-1675. doi: 10.1007/s00421-021-04624-5. Epub 2021 Mar 5.
• Trama R, Blache Y, Hintzy F, Rossi J, Millet GY, Hautier C. Does neuromuscular fatigue generated by trail running modify foot-ground impact and soft tissue vibrations? Eur J Sport Sci. 2022 Jul 10:1-9. doi: 10.1080/17461391.2022.2093649. [Epub ahead of print]
• Besson T, Parent A, Brownstein CG, Espeit L, Lapole T, Martin V, Royer N, Rimaud D, Sabater Pastor F, Singh B, Varesco G, Rossi J, Temesi J, Millet GY. Sex Differences in Neuromuscular Fatigue and Changes in Cost of Running after Mountain Trail Races of Various Distances. Med Sci Sports Exerc. 2021 Nov 1;53(11):2374-2387. doi: 10.1249/MSS.0000000000002719.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation (TMS); Sex differences; Ultra-endurance running; Mont Blanc Ultra Trail; Neuromuscular tests; Plantar flexors; Knee extensors; Force/Velocity Profile (FVP)
• Other Study ID 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