search
Back to results

Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling (FAT-CENTR)

Primary Purpose

Ultra-marathon Runners

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
maximum effort test on a cycloergometer
maximum effort test on a treadmill
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ultra-marathon Runners focused on measuring central fatigue, peripheral fatigue, ultra-endurance exercise, corticospinal excitability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Running endurance

Cycling endurance

Arm Description

Athletes wiil run for 5 hours in a row.

Athletes wiil cycle for 5 hours in a row.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Spinal excitability
thoracic spine stimulation for the recording of thoracic motor evoked potentials
Corticospinal excitability
stimulation of the motor cortex for recording motor evoked potentials
Cortical excitability
ratio between stimulation of the motor cortex and thoracic spine stimulation
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.
Measurement of speed, force and power values
assessment of fatigue in dynamic mode (calculation of the force/speed profile)
Red blood cells
blood sample
Platelets
blood sample
White blood cells
blood sample
Hemoglobin
blood sample
Mean corpuscular hemoglobin concentration
blood sample
C-reactive protein
blood sample
Creatine PhosphoKinase
blood sample
Interleukines
blood sample
Lactate
blood sample
Measurement of the time maintained at the speed corresponding to the 2nd ventilatory threshold
On treadmill
measurement of the time maintained at the power corresponding to the 2nd ventilatory threshold
On Cycloergometer

Full Information

First Posted
July 31, 2020
Last Updated
November 23, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT04511858
Brief Title
Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling
Acronym
FAT-CENTR
Official Title
Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultra-marathon Runners
Keywords
central fatigue, peripheral fatigue, ultra-endurance exercise, corticospinal excitability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Running endurance
Arm Type
Experimental
Arm Description
Athletes wiil run for 5 hours in a row.
Arm Title
Cycling endurance
Arm Type
Experimental
Arm Description
Athletes wiil cycle for 5 hours in a row.
Intervention Type
Other
Intervention Name(s)
maximum effort test on a cycloergometer
Intervention Description
5 h test on cycloergometer
Intervention Type
Other
Intervention Name(s)
maximum effort test on a treadmill
Intervention Description
5 h test on treadmill
Primary Outcome Measure Information:
Title
Maximum level of voluntary activation of relative central fatigue
Description
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
Time Frame
Before and immediately after 5h exercise
Secondary Outcome Measure Information:
Title
Maximum level of voluntary activation of fatigue centrale absolute
Description
measured in isometric mode of the knee extensors, between the value before the 5h cycling or running and the value after absolute exhaustion
Time Frame
Before and immediately after 5h exercise
Title
Maximum level of voluntary activation with electrical evoked activation
Description
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
Time Frame
Before and immediately after 5h exercise
Title
Spinal excitability
Description
thoracic spine stimulation for the recording of thoracic motor evoked potentials
Time Frame
Before and immediately after 5h exercise
Title
Corticospinal excitability
Description
stimulation of the motor cortex for recording motor evoked potentials
Time Frame
Before and immediately after 5h exercise
Title
Cortical excitability
Description
ratio between stimulation of the motor cortex and thoracic spine stimulation
Time Frame
Before and immediately after 5h exercise
Title
Measurement of isometric force values
Description
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.
Time Frame
Before and immediately after 5h exercise
Title
Measurement of speed, force and power values
Description
assessment of fatigue in dynamic mode (calculation of the force/speed profile)
Time Frame
Before and immediately after 5h exercise
Title
Red blood cells
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
Platelets
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
White blood cells
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
Hemoglobin
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
Mean corpuscular hemoglobin concentration
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
C-reactive protein
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
Creatine PhosphoKinase
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
Interleukines
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
Lactate
Description
blood sample
Time Frame
Before and immediately after 5h exercise
Title
Measurement of the time maintained at the speed corresponding to the 2nd ventilatory threshold
Description
On treadmill
Time Frame
Before and immediately after 5h exercise
Title
measurement of the time maintained at the power corresponding to the 2nd ventilatory threshold
Description
On Cycloergometer
Time Frame
Before and immediately after 5h exercise

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillaume MILLET, PhD
Organizational Affiliation
SAINT-ETIENNE UNIVERSITY
Official's Role
Study Director
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling

We'll reach out to this number within 24 hrs