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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04511858
Other study ID # 19CH217
Secondary ID 2020-A01714-35
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2021
Est. completion date July 15, 2021

Study information

Verified date November 2021
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date July 15, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
maximum effort test on a cycloergometer
5 h test on cycloergometer
maximum effort test on a treadmill
5 h test on treadmill

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Before and immediately after 5h exercise
Secondary 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 Before and immediately after 5h exercise
Secondary 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 Before and immediately after 5h exercise
Secondary Spinal excitability thoracic spine stimulation for the recording of thoracic motor evoked potentials Before and immediately after 5h exercise
Secondary Corticospinal excitability stimulation of the motor cortex for recording motor evoked potentials Before and immediately after 5h exercise
Secondary Cortical excitability ratio between stimulation of the motor cortex and thoracic spine stimulation Before and immediately after 5h exercise
Secondary 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. Before and immediately after 5h exercise
Secondary Measurement of speed, force and power values assessment of fatigue in dynamic mode (calculation of the force/speed profile) Before and immediately after 5h exercise
Secondary Red blood cells blood sample Before and immediately after 5h exercise
Secondary Platelets blood sample Before and immediately after 5h exercise
Secondary White blood cells blood sample Before and immediately after 5h exercise
Secondary Hemoglobin blood sample Before and immediately after 5h exercise
Secondary Mean corpuscular hemoglobin concentration blood sample Before and immediately after 5h exercise
Secondary C-reactive protein blood sample Before and immediately after 5h exercise
Secondary Creatine PhosphoKinase blood sample Before and immediately after 5h exercise
Secondary Interleukines blood sample Before and immediately after 5h exercise
Secondary Lactate blood sample Before and immediately after 5h exercise
Secondary Measurement of the time maintained at the speed corresponding to the 2nd ventilatory threshold On treadmill Before and immediately after 5h exercise
Secondary measurement of the time maintained at the power corresponding to the 2nd ventilatory threshold On Cycloergometer Before and immediately after 5h exercise
See also
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