NCT04719975

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

September 22, 2020

Last Update Submit

January 19, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    1 hours 30 minutes - 2 hours

  • Reaction Time Flanker Task

    Reaction Time will be assessed during Flanker task

    Total of 10 minutes

  • Accuracy Flanker Task

    Accuracy will be assessed during Flanker task

    Total of 10 minutes

  • Reaction Time Stroop Task

    Reaction Time will be assessed during Stroop task

    60 minutes

  • Accuracy performance Stroop Task

    Accuracy will be assessed during Stroop task

    60 minutes

Study Arms (4)

Mental Fatigue (Stroop) - Chair task

EXPERIMENTAL

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.

Other: Mental Fatigue (Stroop task)

Control Task (Documentary) - Chair Task

PLACEBO COMPARATOR

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.

Other: Control (Documentary)

Mental Fatigue (Stroop) - Bike Task

EXPERIMENTAL

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.

Other: Mental Fatigue (Stroop task)

Control task (Documentary) - Bike Task

PLACEBO COMPARATOR

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.

Other: Control (Documentary)

Interventions

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.

Mental Fatigue (Stroop) - Bike TaskMental Fatigue (Stroop) - Chair task

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.

Control Task (Documentary) - Chair TaskControl task (Documentary) - Bike Task

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Physiology and Sports Physiotherapy Research Group

Brussels, Elsene, 1050, Belgium

Location

Related Publications (1)

  • Proost M, Habay J, DE Wachter J, DE Pauw K, Marusic U, Meeusen R, DE Bock S, Roelands B, VAN Cutsem J. The Impact of Mental Fatigue on a Strength Endurance Task: Is There a Role for the Movement-Related Cortical Potential? Med Sci Sports Exerc. 2024 Mar 1;56(3):435-445. doi: 10.1249/MSS.0000000000003322. Epub 2023 Oct 16.

MeSH Terms

Conditions

Mental Fatigue

Interventions

Stroop Test

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Matthias Proost, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, blinded, counter-balanced, cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2020

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations