Ultra-marathon RunnersUTMB_2019NCT04025138
Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains
A study testing Neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS) and Neuromuscular fatigue assessment test in people with Ultra-marathon Runners, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultra-marathon Runners
- What is being tested?
- Neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS) and Neuromuscular fatigue assessment test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject listed in the race "2019 Mont Blanc Ultra Trail"
- Affiliates or beneficiaries of social security scheme
- Signed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the 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).
- Conditions
- Ultra-marathon Runners
- Being tested
- Neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), Neuromuscular fatigue assessment test, treadmill, Blood sample
- Keywords
- Sex differences, Ultra-endurance running, Mont Blanc Ultra Trail, Transcranial Magnetic Stimulation (TMS), Neuromuscular tests, Plantar flexors, Knee extensors, Force/Velocity Profile (FVP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular tests in isometric modeOther
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)
Transcranial Magnetic Stimulation (TMS)Device
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).
Neuromuscular fatigue assessment testOther
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.
treadmillOther
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.
Blood sampleBiological
Blood sample will be realized to measure hemorrheologic and hematologic parameters.
Urinary sampleBiological
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neuromuscular tests in isometric mode; Device: Transcranial Magnetic Stimulation (TMS); Other: Neuromuscular fatigue assessment test; Other: treadmill; Biological: Blood sample; Biological: 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. Receives: Other: Neuromuscular tests in isometric mode; Device: Transcranial Magnetic Stimulation (TMS); Other: Neuromuscular fatigue assessment test; Other: treadmill; Biological: Blood sample; Biological: 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. Receives: Other: Neuromuscular tests in isometric mode; Device: Transcranial Magnetic Stimulation (TMS); Other: Neuromuscular fatigue assessment test; Other: treadmill; Biological: Blood sample; Biological: 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. Receives: Other: Neuromuscular tests in isometric mode; Device: Transcranial Magnetic Stimulation (TMS); Other: Neuromuscular fatigue assessment test; Other: treadmill; Biological: Blood sample; Biological: Urinary sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation (%) of the amplitudes of the electric shock
Measured by the electrically evoked force after contraction in isometric mode of the plantar flexors
Measured: 5 or 6 day before the race and 1 hour after
Secondary outcomes (19)
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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 5 or 6 day before the race and 1 hour after
Blood viscosity
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
Number of red blood cell
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
Number of platelets
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
Number of white blood cells
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
Rate of hemoglobin (%)
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
creatinine (mg/L)
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
C reactive protein (CRP) (mg/L)
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
urea (g/L)
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
uric acid (mg/L)
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
lactate (mg/L)
Measured by blood sample.
Measured: 5 or 6 day before the race and 1 hour after
Proteinuria-density urinary (mg/24h)
Measured by urinary sample.
Measured: 5 or 6 day before the race and 1 hour after
Kinematic variable
Measured by treadmill result.
Measured: 5 or 6 day before the race and 1 hour after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start2 Jul 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ultra-marathon RunnersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léonard FEASSON, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneGuillaume MILLET, PhD, Study director, University of Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025138
- Sponsor's protocol ID
- 19CH060
- Other IDs
- 2019-A00736-51
- Acronym
- UTMB_2019
- Status last verified
- Dec 2022
- First submitted
- 3 Jul 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33198320Temesi 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.
PubMed 34170574Foure 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.
PubMed 35730335Pastor 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.
PubMed 35213820Sabater 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.
PubMed 33666727Trama 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.
PubMed 35730761Besson 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.
PubMed 34107510
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains
- ClinicalTrials.gov ID
- NCT04025138
- Acronym / sponsor ID
- UTMB_2019 / 19CH060
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| female subjects involved in races over 100 km (F>100) | Experimental | Other: Neuromuscular tests in isometric mode, Device: Transcranial Magnetic Stimulation (TMS), Other: Neuromuscular fatigue assessment test, Other: treadmill, Biological: Blood sample, Biological: Urinary sampleFemale 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) | Experimental | Other: Neuromuscular tests in isometric mode, Device: Transcranial Magnetic Stimulation (TMS), Other: Neuromuscular fatigue assessment test, Other: treadmill, Biological: Blood sample, Biological: Urinary sampleFemale 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) | Experimental | Other: Neuromuscular tests in isometric mode, Device: Transcranial Magnetic Stimulation (TMS), Other: Neuromuscular fatigue assessment test, Other: treadmill, Biological: Blood sample, Biological: Urinary sampleMale 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) | Experimental | Other: Neuromuscular tests in isometric mode, Device: Transcranial Magnetic Stimulation (TMS), Other: Neuromuscular fatigue assessment test, Other: treadmill, Biological: Blood sample, Biological: Urinary sampleMale 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject listed in the race "2019 Mont Blanc Ultra Trail"
- Affiliates or beneficiaries of social security scheme
- Signed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular tests in isometric modeProtocol 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) | Other | 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) |
| Transcranial Magnetic Stimulation (TMS)Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS). | Device | 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 testNeuromuscular 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 | 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) |
| treadmill2 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. | Other | 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 sampleBlood sample will be realized to measure hemorrheologic and hematologic parameters. | Biological | 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 sampleUrinary sample will be realized to measure hemorrheologic and hematologic parameters. | Biological | 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) |
Primary outcome
Variation (%) of the amplitudes of the electric shock
Time frame: 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
19 secondary outcomes
Voluntary maximum forces plantar flexors
Time frame: 5 or 6 day before the race and 1 hour after
Voluntary maximum forces knee extensors
Time frame: 5 or 6 day before the race and 1 hour after
Electrically evoked forces
Time frame: 5 or 6 day before the race and 1 hour after
ElectroMyoGraphic activity (EMG)
Time frame: 5 or 6 day before the race and 1 hour after
Three-Modality Evoked Potentials (TMEPs)
Time frame: 5 or 6 day before the race and 1 hour after
Transcranial Magnetic Stimulation (TMS)
Time frame: 5 or 6 day before the race and 1 hour after
Force/Velocity Profile (FVP)
Time frame: 5 or 6 day before the race and 1 hour after
Blood viscosity
Time frame: 5 or 6 day before the race and 1 hour after
Number of red blood cell
Time frame: 5 or 6 day before the race and 1 hour after
Number of platelets
Time frame: 5 or 6 day before the race and 1 hour after
Number of white blood cells
Time frame: 5 or 6 day before the race and 1 hour after
Rate of hemoglobin (%)
Time frame: 5 or 6 day before the race and 1 hour after
creatinine (mg/L)
Time frame: 5 or 6 day before the race and 1 hour after
C reactive protein (CRP) (mg/L)
Time frame: 5 or 6 day before the race and 1 hour after
urea (g/L)
Time frame: 5 or 6 day before the race and 1 hour after
uric acid (mg/L)
Time frame: 5 or 6 day before the race and 1 hour after
lactate (mg/L)
Time frame: 5 or 6 day before the race and 1 hour after
Proteinuria-density urinary (mg/24h)
Time frame: 5 or 6 day before the race and 1 hour after
Kinematic variable
Time frame: 5 or 6 day before the race and 1 hour after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Results publication: PubMed 33198320Robert 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.
- Results publication: PubMed 34170574Temesi 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.
- Results publication: PubMed 35730335Foure 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.
- Results publication: PubMed 35213820Pastor 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.
- Results publication: PubMed 33666727Sabater 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.
- Derived from this study: PubMed 35730761Trama 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.
- Derived from this study: PubMed 34107510Besson 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Léonard FEASSON, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Guillaume MILLET, PhD study director
University of Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS) and Neuromuscular fatigue assessment test in people with Ultra-marathon Runners, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation (%) of the amplitudes of the electric shock (time frame: 5 or 6 day before the race and 1 hour after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025138, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.