NCT04025138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

July 3, 2019

Last Update Submit

December 13, 2022

Conditions

Keywords

Sex differencesUltra-endurance runningMont Blanc Ultra TrailTranscranial Magnetic Stimulation (TMS)Neuromuscular testsPlantar flexorsKnee extensorsForce/Velocity Profile (FVP)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Voluntary maximum forces plantar flexors

    5 or 6 day before the race and 1 hour after

  • Voluntary maximum forces knee extensors

    5 or 6 day before the race and 1 hour after

  • Electrically evoked forces

    5 or 6 day before the race and 1 hour after

  • ElectroMyoGraphic activity (EMG)

    5 or 6 day before the race and 1 hour after

  • Three-Modality Evoked Potentials (TMEPs)

    5 or 6 day before the race and 1 hour after

  • +14 more secondary outcomes

Study Arms (4)

female subjects involved in races over 100 km (F>100)

EXPERIMENTAL

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 modeDevice: Transcranial Magnetic Stimulation (TMS)Other: Neuromuscular fatigue assessment testOther: treadmillBiological: Blood sampleBiological: Urinary sample

female subjects involved in races less than 60 km (F<60)

EXPERIMENTAL

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 modeDevice: Transcranial Magnetic Stimulation (TMS)Other: Neuromuscular fatigue assessment testOther: treadmillBiological: Blood sampleBiological: Urinary sample

male subjects involved in races over 100 km (H>100)

EXPERIMENTAL

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 modeDevice: Transcranial Magnetic Stimulation (TMS)Other: Neuromuscular fatigue assessment testOther: treadmillBiological: Blood sampleBiological: Urinary sample

male subjects involved in races less than 60 km (H<60)

EXPERIMENTAL

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 modeDevice: Transcranial Magnetic Stimulation (TMS)Other: Neuromuscular fatigue assessment testOther: treadmillBiological: Blood sampleBiological: Urinary sample

Interventions

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)

female subjects involved in races less than 60 km (F<60)female subjects involved in races over 100 km (F>100)male subjects involved in races less than 60 km (H<60)male subjects involved in races over 100 km (H>100)

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

female subjects involved in races less than 60 km (F<60)female subjects involved in races over 100 km (F>100)male subjects involved in races less than 60 km (H<60)male subjects involved in races over 100 km (H>100)

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.

female subjects involved in races less than 60 km (F<60)female subjects involved in races over 100 km (F>100)male subjects involved in races less than 60 km (H<60)male subjects involved in races over 100 km (H>100)

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.

female subjects involved in races less than 60 km (F<60)female subjects involved in races over 100 km (F>100)male subjects involved in races less than 60 km (H<60)male subjects involved in races over 100 km (H>100)
Blood sampleBIOLOGICAL

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

female subjects involved in races less than 60 km (F<60)female subjects involved in races over 100 km (F>100)male subjects involved in races less than 60 km (H<60)male subjects involved in races over 100 km (H>100)
Urinary sampleBIOLOGICAL

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

female subjects involved in races less than 60 km (F<60)female subjects involved in races over 100 km (F>100)male subjects involved in races less than 60 km (H<60)male subjects involved in races over 100 km (H>100)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

Related Publications (7)

  • 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. 2023 Jul;23(7):1155-1163. doi: 10.1080/17461391.2022.2093649. Epub 2022 Jul 10.

  • 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.

MeSH Terms

Interventions

Transcranial Magnetic StimulationExercise TestBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, Operative

Study Officials

  • LĂ©onard FEASSON, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR
  • Guillaume MILLET, PhD

    University of Saint-Etienne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 18, 2019

Study Start

July 2, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations