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:
According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ultra-marathon Runners | Other: Neuromuscular tests in isometric mode Device: Transcranial Magnetic Stimulation (TMS) Other: Neuromuscular fatigue assessment test Other: treadmill Biological: Blood sample Biological: Urinary sample | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains |
| Actual Study Start Date : | July 2, 2019 |
| Actual Primary Completion Date : | September 1, 2019 |
| Actual Study Completion Date : | September 1, 2019 |
| 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 :
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 :
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 :
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 :
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.
|
Analysis :
Measured by voluntary maximum forces plantar flexors test (seat type Cybex) in percentage (%).
Analysis :
Voluntary maximum forces knee extensors measures by seat type Cybex in percentage (%).
Analysis :
Electrically evoked forces measures by neurostimulator in percentage (%).
Analysis :
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.
Analysis :
Three-Modality Evoked Potentials (TMEPs) measures by magnetic stimulator in percentage (%).
Analysis :
Measured supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS) in percentage (%).
Analysis:
Measured Force/Velocity Profile (FVP) test: 2 sprints of 8 seconds on a cycle ergometer.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| France | |
| CHU Saint-Etienne | |
| Saint-Étienne, France | |
| Principal Investigator: | Léonard FEASSON, MD PhD | CHU SAINT-ETIENNE | |
| Study Director: | Guillaume MILLET, PhD | University of Saint-Etienne |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 3, 2019 | ||||||
| First Posted Date ICMJE | July 18, 2019 | ||||||
| Last Update Posted Date | September 27, 2019 | ||||||
| Actual Study Start Date ICMJE | July 2, 2019 | ||||||
| Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE |
Variation (%) of the amplitudes of the electric shock [ Time Frame: 5 or 6 day before the race and 1 hour after ] Comparison of variation in the plantar flexor peripheral peak twitch between males and females depending on the distance of the race.
Measured by the electrically evoked force after contraction in isometric mode of the plantar flexors
|
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains | ||||||
| Official Title ICMJE | Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains | ||||||
| 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:
According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running. |
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| 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 ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | Ultra-marathon Runners | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
75 | ||||||
| Original Estimated Enrollment ICMJE |
86 | ||||||
| Actual Study Completion Date ICMJE | September 1, 2019 | ||||||
| Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | France | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04025138 | ||||||
| Other Study ID Numbers ICMJE | 19CH060 2019-A00736-51 ( Other Identifier: ANSM ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | ||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Centre Hospitalier Universitaire de Saint Etienne | ||||||
| Verification Date | September 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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