Clinical trial NCT04025138: Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains
Official title: Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultra-marathon Runners
Keywords: Sex differences
Ultra-endurance running
Mont Blanc Ultra Trail
Transcranial Magnetic Stimulation (TMS)
Neuromuscular tests
Plantar flexors
Knee extensors
Force/Velocity Profile (FVP)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Variation (%) of the amplitudes of the electric shock
timeFrame: 5 or 6 day before the race and 1 hour after
Secondary outcomes:
measure: Voluntary maximum forces plantar flexors
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Voluntary maximum forces knee extensors
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Electrically evoked forces
timeFrame: 5 or 6 day before the race and 1 hour after
measure: ElectroMyoGraphic activity (EMG)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Three-Modality Evoked Potentials (TMEPs)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Transcranial Magnetic Stimulation (TMS)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Force/Velocity Profile (FVP)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Blood viscosity
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Number of red blood cell
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Number of platelets
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Number of white blood cells
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Rate of hemoglobin (%)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: creatinine (mg/L)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: C reactive protein (CRP) (mg/L)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: urea (g/L)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: uric acid (mg/L)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: lactate (mg/L)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Proteinuria-density urinary (mg/24h)
timeFrame: 5 or 6 day before the race and 1 hour after
measure: Kinematic variable
timeFrame: 5 or 6 day before the race and 1 hour after
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Léonard FEASSON, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saint-Etienne
name: Guillaume MILLET, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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. 2023 Jul;23(7):1155-1163. doi: 10.1080/17461391.2022.2093649. Epub 2022 Jul 10.
citation: 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.