Ultra-marathon RunnersFAT-CENTRNCT04511858
Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling
A study testing maximum effort test on a cycloergometer and maximum effort test on a treadmill in people with Ultra-marathon Runners, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. Ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ultra-marathon Runners
- What is being tested?
- maximum effort test on a cycloergometer and maximum effort test on a treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2021to 15 Jul 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Specialist in endurance and ultra-endurance. in the 2 disciplines: running and cycling (triathletes, duathletes or trailers achieving at least 30% of their training volume in cycling), and having at least finished one long distance event in the last 2 years,
- Affiliated or beneficiary of a social security scheme.
- Signature of the consent form
Who cannot join
- Any subject who has been injured in the 3 months prior to the protocol
- Anyone with chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems).
- Any subject with chronic or central neurological pathologies
- Any subject with a contraindication to magnetic stimulation
- Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) on the study.
- Contraindication to the application of a magnetic field:
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- Heart or respiratory insufficiency.
- Subject with a cardiac pace maker.
- Cardiac valve wear and serious cardiovascular diseases.
- Presence of prosthetic material or ferromagnetic foreign bodies in the head.
- Presence of cochlear implants or ocular prosthetic material.
- History of neurosurgical interventions.
- Neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumour, multiple sclerosis, history of stroke or traumatic brain injury).
- History of comitiality, contralateral knee disease or musculoskeletal disease.
- Any subject participating at the same time in another interventional experiment requiring physical exercise.
- Any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).
- Any subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
The mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. Ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. This protocol will compare fatigue during and after ultra-endurance exercise bouts that result in moderate lower-limb tissue damage (i.e. cycling) or significant damage (i.e. running). The results of this protocol will allow us to further understanding of the reasons for major central fatigue, i.e. within the central nervous system, in ultra-endurance.
- Conditions
- Ultra-marathon Runners
- Being tested
- maximum effort test on a cycloergometer, maximum effort test on a treadmill
- Keywords
- central fatigue, peripheral fatigue, ultra-endurance exercise, corticospinal excitability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maximum effort test on a cycloergometerOther
5 h test on cycloergometer
maximum effort test on a treadmillOther
5 h test on treadmill
| Study group | Role | What they receive |
|---|---|---|
| Running endurance | Experimental | Athletes wiil run for 5 hours in a row. Receives: Other: maximum effort test on a treadmill |
| Cycling endurance | Experimental | Athletes wiil cycle for 5 hours in a row. Receives: Other: maximum effort test on a cycloergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum level of voluntary activation of relative central fatigue
measured in isometric mode of the knee extensors, between the value before and immediately after a 5-hour cycling or running event at the same relative intensity
Measured: Before and immediately after 5h exercise
Secondary outcomes (18)
Maximum level of voluntary activation of fatigue centrale absolute
measured in isometric mode of the knee extensors, between the value before the 5h cycling or running and the value after absolute exhaustion
Measured: Before and immediately after 5h exercise
Maximum level of voluntary activation with electrical evoked activation
tests with measurement of the maximum voluntary with evoked electrical between the value before and immediately after a 5-hour cycling or running event at the same relative intensity
Measured: Before and immediately after 5h exercise
Spinal excitability
thoracic spine stimulation for the recording of thoracic motor evoked potentials
Measured: Before and immediately after 5h exercise
Corticospinal excitability
stimulation of the motor cortex for recording motor evoked potentials
Measured: Before and immediately after 5h exercise
Cortical excitability
ratio between stimulation of the motor cortex and thoracic spine stimulation
Measured: Before and immediately after 5h exercise
Measurement of isometric force values
subjects sitting on a Cybex type seat, with the knee and hip angle set at 90°. The foot will be attached to a strain-gauge sensor using a velcro strap attached to the ankle above the medial malleolus.
Measured: Before and immediately after 5h exercise
Measurement of speed, force and power values
assessment of fatigue in dynamic mode (calculation of the force/speed profile)
Measured: Before and immediately after 5h exercise
Red blood cells
blood sample
Measured: Before and immediately after 5h exercise
Platelets
blood sample
Measured: Before and immediately after 5h exercise
White blood cells
blood sample
Measured: Before and immediately after 5h exercise
Hemoglobin
blood sample
Measured: Before and immediately after 5h exercise
Mean corpuscular hemoglobin concentration
blood sample
Measured: Before and immediately after 5h exercise
C-reactive protein
blood sample
Measured: Before and immediately after 5h exercise
Creatine PhosphoKinase
blood sample
Measured: Before and immediately after 5h exercise
Interleukines
blood sample
Measured: Before and immediately after 5h exercise
Lactate
blood sample
Measured: Before and immediately after 5h exercise
Measurement of the time maintained at the speed corresponding to the 2nd ventilatory threshold
On treadmill
Measured: Before and immediately after 5h exercise
measurement of the time maintained at the power corresponding to the 2nd ventilatory threshold
On Cycloergometer
Measured: Before and immediately after 5h exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start5 Mar 2021
- Primary completion28 May 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra-marathon RunnersStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective study of physiopathology on subjects specializing in endurance and ultra-endurance: comparing running vs. cycling. Cross-over: each subject will carry out the 2 experimental conditions (running and cycling) according to a randomized order of passage, respecting a wash-out of 2 weeks.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- 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, SAINT-ETIENNE UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511858
- Sponsor's protocol ID
- 19CH217
- Other IDs
- 2020-A01714-35
- Acronym
- FAT-CENTR
- Status last verified
- Nov 2021
- First submitted
- 31 Jul 2020
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling
- ClinicalTrials.gov ID
- NCT04511858
- Acronym / sponsor ID
- FAT-CENTR / 19CH217
- Conditions
- Ultra-marathon Runners
- Keywords
- central fatigue, peripheral fatigue, ultra-endurance exercise, corticospinal excitability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 13 Aug 2020 (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.
The mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. Ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. This protocol will compare fatigue during and after ultra-endurance exercise bouts that result in moderate lower-limb tissue damage (i.e. cycling) or significant damage (i.e. running). The results of this protocol will allow us to further understanding of the reasons for major central fatigue, i.e. within the central nervous system, in ultra-endurance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective study of physiopathology on subjects specializing in endurance and ultra-endurance: comparing running vs. cycling. Cross-over: each subject will carry out the 2 experimental conditions (running and cycling) according to a randomized order of passage, respecting a wash-out of 2 weeks.
| Arm | Type | Receives |
|---|---|---|
| Running endurance | Experimental | Other: maximum effort test on a treadmillAthletes wiil run for 5 hours in a row. |
| Cycling endurance | Experimental | Other: maximum effort test on a cycloergometerAthletes wiil cycle for 5 hours in a row. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Specialist in endurance and ultra-endurance. in the 2 disciplines: running and cycling (triathletes, duathletes or trailers achieving at least 30% of their training volume in cycling), and having at least finished one long distance event in the last 2 years,
- Affiliated or beneficiary of a social security scheme.
- Signature of the consent form
Key exclusion criteria (17 listed)
- Any subject who has been injured in the 3 months prior to the protocol
- Anyone with chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems).
- Any subject with chronic or central neurological pathologies
- Any subject with a contraindication to magnetic stimulation
- Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) on the study.
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 |
|---|---|---|
| maximum effort test on a cycloergometer5 h test on cycloergometer | Other | Cycling endurance |
| maximum effort test on a treadmill5 h test on treadmill | Other | Running endurance |
Primary outcome
Maximum level of voluntary activation of relative central fatigue
Time frame: Before and immediately after 5h exercise
measured in isometric mode of the knee extensors, between the value before and immediately after a 5-hour cycling or running event at the same relative intensity
18 secondary outcomes
Maximum level of voluntary activation of fatigue centrale absolute
Time frame: Before and immediately after 5h exercise
Maximum level of voluntary activation with electrical evoked activation
Time frame: Before and immediately after 5h exercise
Spinal excitability
Time frame: Before and immediately after 5h exercise
Corticospinal excitability
Time frame: Before and immediately after 5h exercise
Cortical excitability
Time frame: Before and immediately after 5h exercise
Measurement of isometric force values
Time frame: Before and immediately after 5h exercise
Measurement of speed, force and power values
Time frame: Before and immediately after 5h exercise
Red blood cells
Time frame: Before and immediately after 5h exercise
Platelets
Time frame: Before and immediately after 5h exercise
White blood cells
Time frame: Before and immediately after 5h exercise
Hemoglobin
Time frame: Before and immediately after 5h exercise
Mean corpuscular hemoglobin concentration
Time frame: Before and immediately after 5h exercise
C-reactive protein
Time frame: Before and immediately after 5h exercise
Creatine PhosphoKinase
Time frame: Before and immediately after 5h exercise
Interleukines
Time frame: Before and immediately after 5h exercise
Lactate
Time frame: Before and immediately after 5h exercise
Measurement of the time maintained at the speed corresponding to the 2nd ventilatory threshold
Time frame: Before and immediately after 5h exercise
measurement of the time maintained at the power corresponding to the 2nd ventilatory threshold
Time frame: Before and immediately after 5h exercise
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 24 Nov 2021.
- 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
SAINT-ETIENNE UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maximum effort test on a cycloergometer and maximum effort test on a treadmill 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 17 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 24 Nov 2021. 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?
Maximum level of voluntary activation of relative central fatigue (time frame: Before and immediately after 5h exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2021.