NCT04511858

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

July 31, 2020

Last Update Submit

November 23, 2021

Conditions

Keywords

central fatigueperipheral fatigueultra-endurance exercisecorticospinal excitability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Maximum level of voluntary activation of fatigue centrale absolute

    Before and immediately after 5h exercise

  • Maximum level of voluntary activation with electrical evoked activation

    Before and immediately after 5h exercise

  • Spinal excitability

    Before and immediately after 5h exercise

  • Corticospinal excitability

    Before and immediately after 5h exercise

  • Cortical excitability

    Before and immediately after 5h exercise

  • +13 more secondary outcomes

Study Arms (2)

Running endurance

EXPERIMENTAL

Athletes wiil run for 5 hours in a row.

Other: maximum effort test on a treadmill

Cycling endurance

EXPERIMENTAL

Athletes wiil cycle for 5 hours in a row.

Other: maximum effort test on a cycloergometer

Interventions

5 h test on cycloergometer

Cycling endurance

5 h test on treadmill

Running endurance

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42000, France

Location

Study Officials

  • Léonard FEASSON, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR
  • Guillaume MILLET, PhD

    SAINT-ETIENNE UNIVERSITY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 13, 2020

Study Start

March 5, 2021

Primary Completion

May 28, 2021

Study Completion

July 15, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations