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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04025138
Other study ID # 19CH060
Secondary ID 2019-A00736-51
Status Completed
Phase N/A
First received
Last updated
Start date July 2, 2019
Est. completion date September 1, 2019

Study information

Verified date December 2022
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

References & Publications (5)

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 — View 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/ij — View 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. — View 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. — View 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): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Blood viscosity Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary Number of red blood cell Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary Number of platelets Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary Number of white blood cells Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary Rate of hemoglobin (%) Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary creatinine (mg/L) Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary C reactive protein (CRP) (mg/L) Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary urea (g/L) Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary uric acid (mg/L) Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary lactate (mg/L) Measured by blood sample. 5 or 6 day before the race and 1 hour after
Secondary Proteinuria-density urinary (mg/24h) Measured by urinary sample. 5 or 6 day before the race and 1 hour after
Secondary Kinematic variable Measured by treadmill result. 5 or 6 day before the race and 1 hour after
See also
  Status Clinical Trial Phase
Completed NCT04511858 - Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling N/A