- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511858
Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling (FAT-CENTR)
November 23, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Étienne, France, 42000
- Chu Saint-Etienne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Running endurance
Athletes wiil run for 5 hours in a row.
|
5 h test on treadmill
|
|
Experimental: Cycling endurance
Athletes wiil cycle for 5 hours in a row.
|
5 h test on cycloergometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Before and immediately after 5h exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum level of voluntary activation of fatigue centrale absolute
Time Frame: Before and immediately after 5h exercise
|
measured in isometric mode of the knee extensors, between the value before the 5h cycling or running and the value after absolute exhaustion
|
Before and immediately after 5h exercise
|
|
Maximum level of voluntary activation with electrical evoked activation
Time Frame: Before and immediately after 5h exercise
|
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
|
Before and immediately after 5h exercise
|
|
Spinal excitability
Time Frame: Before and immediately after 5h exercise
|
thoracic spine stimulation for the recording of thoracic motor evoked potentials
|
Before and immediately after 5h exercise
|
|
Corticospinal excitability
Time Frame: Before and immediately after 5h exercise
|
stimulation of the motor cortex for recording motor evoked potentials
|
Before and immediately after 5h exercise
|
|
Cortical excitability
Time Frame: Before and immediately after 5h exercise
|
ratio between stimulation of the motor cortex and thoracic spine stimulation
|
Before and immediately after 5h exercise
|
|
Measurement of isometric force values
Time Frame: Before and immediately after 5h exercise
|
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.
|
Before and immediately after 5h exercise
|
|
Measurement of speed, force and power values
Time Frame: Before and immediately after 5h exercise
|
assessment of fatigue in dynamic mode (calculation of the force/speed profile)
|
Before and immediately after 5h exercise
|
|
Red blood cells
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
Platelets
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
White blood cells
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
Hemoglobin
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
Mean corpuscular hemoglobin concentration
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
C-reactive protein
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
Creatine PhosphoKinase
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
Interleukines
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
Before and immediately after 5h exercise
|
|
Lactate
Time Frame: Before and immediately after 5h exercise
|
blood sample
|
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
|
On treadmill
|
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
|
On Cycloergometer
|
Before and immediately after 5h exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Guillaume MILLET, PhD, Saint-Etienne University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2021
Primary Completion (Actual)
May 28, 2021
Study Completion (Actual)
July 15, 2021
Study Registration Dates
First Submitted
July 31, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (Actual)
August 13, 2020
Study Record Updates
Last Update Posted (Actual)
November 24, 2021
Last Update Submitted That Met QC Criteria
November 23, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19CH217
- 2020-A01714-35 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ultra-marathon Runners
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Keller Army Community HospitalRecruitingHealthy RunnersUnited States
-
National Taiwan Sport UniversityNot yet recruiting
-
Lake Erie College of Osteopathic MedicineLake Erie College of Osteopathic Medicine (LECOM)Completed
-
Medical University of GdanskActive, not recruitingIntestinal Microbiome | Probiotic | RunnersPoland
-
Pedro Julian Flores MorenoFabian Rojas Larios; Claudia Ivette Gamboa GomezNot yet recruitingHealthy Adult Male | RunnersMexico
-
University of HaifaCompletedHealthy Runners. Compression Stocking and PerformanceIsrael
-
Hacettepe UniversityCompletedRange of Motion | Mobility | Fascia | RunnersTurkey
-
Philips Electronics Nederland B.V. acting through...Leiden University Medical CenterTerminated
Clinical Trials on maximum effort test on a treadmill
-
Hopital FochCompletedWalking, DifficultyFrance
-
Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceCompletedRhabdomyolysis Linked to a Hereditary Disease of MetabolismFrance
-
Nantes University HospitalCompleted
-
University Hospital, Clermont-FerrandRecruitingHealthy | Overweight | MenFrance
-
Poznan University of Physical EducationCompleted
-
University Hospital, GhentUniversity Ghent; Vrije Universiteit Brussel; VU University of AmsterdamRecruiting
-
The University of Hong KongThe Hong Kong Polytechnic University; Griffith UniversityCompletedBroad Autism PhenotypeHong Kong
-
Spanish National Research CouncilHospital Beata María AnaCompletedHemiparesis/Hemiplegia (One Sided Weakness/Paralysis)Spain
-
Spanish National Research CouncilHospital Beata María AnaCompletedHemiparesis/Hemiplegia (One Sided Weakness/Paralysis)Spain
-
Joslin Diabetes CenterCompletedHypoglycemia | Physical Activity | Roux-en-Y Gastric Bypass | Post-bariatric HypoglycemiaUnited States