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The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance

Primary Purpose

Mental Fatigue, Electroencephalography

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mental Fatigue (Stroop task)
Control (Documentary)
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mental Fatigue

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy (No neurological or cardiovascular disorders)
  • Male or female
  • No medication
  • Non-smoker
  • Between 18 and 35 years old
  • Recreational athlete population (performance level 2 or 3 for men according to De Pauw et al. (2013) and performance level 2 or 3 for woman according to Decroix et al. (2016)

Exclusion Criteria:

  • Injuries over the last 6 months
  • Suffering from any cardiovascular condition
  • Use of medication
  • Suffering from other health conditions at the time of testing
  • Use of caffeine or alcohol 24 hours prior to each trial
  • Heavy efforts 24 hours prior to each trial

Sites / Locations

  • Human Physiology and Sports Physiotherapy Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Mental Fatigue (Stroop) - Chair task

Control Task (Documentary) - Chair Task

Mental Fatigue (Stroop) - Bike Task

Control task (Documentary) - Bike Task

Arm Description

Participants will be performing the Chair Task (150 submaximal dynamic knee extensions at 50% of their maximal voluntary contraction (MVC)) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured.

In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Chair Task, During the whole trial EEG will be measured.

Participants will be performing the Bike Task (a 9 min cycling task performed at 45 rpm with intensity being constant and will be 10% below VT) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured.

In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Bike Task, During the whole trial EEG will be measured.

Outcomes

Primary Outcome Measures

Electroencephalogram data
During whole of the trials EEG data will be gathered, each trial will last one and a half to two hours. EEG power in delta, theta, alpha, beta band.
Reaction Time Flanker Task
Reaction Time will be assessed during Flanker task
Accuracy Flanker Task
Accuracy will be assessed during Flanker task
Reaction Time Stroop Task
Reaction Time will be assessed during Stroop task
Accuracy performance Stroop Task
Accuracy will be assessed during Stroop task

Secondary Outcome Measures

Full Information

First Posted
September 22, 2020
Last Updated
January 19, 2021
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04719975
Brief Title
The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
Official Title
The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this project is to provide further insights into the neurophysiology behind the MF-induced impairment in endurance performance. The aim is to perform a randomized controlled trial in which we partly replicate studies of Marcora et al. (2009) and Bigliassi et al. (2017), while extensively monitoring brain activity during the entire protocol (i.e. both cognitive and physical tasks) by using EEG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue, Electroencephalography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, blinded, counter-balanced, cross-over design
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mental Fatigue (Stroop) - Chair task
Arm Type
Experimental
Arm Description
Participants will be performing the Chair Task (150 submaximal dynamic knee extensions at 50% of their maximal voluntary contraction (MVC)) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured.
Arm Title
Control Task (Documentary) - Chair Task
Arm Type
Placebo Comparator
Arm Description
In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Chair Task, During the whole trial EEG will be measured.
Arm Title
Mental Fatigue (Stroop) - Bike Task
Arm Type
Experimental
Arm Description
Participants will be performing the Bike Task (a 9 min cycling task performed at 45 rpm with intensity being constant and will be 10% below VT) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured.
Arm Title
Control task (Documentary) - Bike Task
Arm Type
Placebo Comparator
Arm Description
In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Bike Task, During the whole trial EEG will be measured.
Intervention Type
Other
Intervention Name(s)
Mental Fatigue (Stroop task)
Intervention Description
A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words ("rood", "blauw", "groen" and "geel") will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself.
Intervention Type
Other
Intervention Name(s)
Control (Documentary)
Intervention Description
In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team. During the control task physiological and psychological measures will be assessed at the same time points as during the mental fatigue trial.
Primary Outcome Measure Information:
Title
Electroencephalogram data
Description
During whole of the trials EEG data will be gathered, each trial will last one and a half to two hours. EEG power in delta, theta, alpha, beta band.
Time Frame
1 hours 30 minutes - 2 hours
Title
Reaction Time Flanker Task
Description
Reaction Time will be assessed during Flanker task
Time Frame
Total of 10 minutes
Title
Accuracy Flanker Task
Description
Accuracy will be assessed during Flanker task
Time Frame
Total of 10 minutes
Title
Reaction Time Stroop Task
Description
Reaction Time will be assessed during Stroop task
Time Frame
60 minutes
Title
Accuracy performance Stroop Task
Description
Accuracy will be assessed during Stroop task
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy (No neurological or cardiovascular disorders) Male or female No medication Non-smoker Between 18 and 35 years old Recreational athlete population (performance level 2 or 3 for men according to De Pauw et al. (2013) and performance level 2 or 3 for woman according to Decroix et al. (2016) Exclusion Criteria: Injuries over the last 6 months Suffering from any cardiovascular condition Use of medication Suffering from other health conditions at the time of testing Use of caffeine or alcohol 24 hours prior to each trial Heavy efforts 24 hours prior to each trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Proost, MSc
Phone
026292753
Email
matthias.proost@vub.be
Facility Information:
Facility Name
Human Physiology and Sports Physiotherapy Research Group
City
Brussel
State/Province
Elsene
ZIP/Postal Code
1050
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance

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