- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04719975
The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
19. januar 2021 opdateret af: Romain Meeusen, Vrije Universiteit Brussel
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Elsene
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Brussel, Elsene, Belgien, 1050
- Human Physiology and Sports Physiotherapy Research Group
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Mental Fatigue (Stroop) - Chair task
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.
|
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.
|
|
Placebo komparator: Control Task (Documentary) - Chair Task
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.
|
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.
|
|
Eksperimentel: Mental Fatigue (Stroop) - Bike Task
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.
|
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.
|
|
Placebo komparator: Control task (Documentary) - Bike Task
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Electroencephalogram data
Tidsramme: 1 hours 30 minutes - 2 hours
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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.
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1 hours 30 minutes - 2 hours
|
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Reaction Time Flanker Task
Tidsramme: Total of 10 minutes
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Reaction Time will be assessed during Flanker task
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Total of 10 minutes
|
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Accuracy Flanker Task
Tidsramme: Total of 10 minutes
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Accuracy will be assessed during Flanker task
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Total of 10 minutes
|
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Reaction Time Stroop Task
Tidsramme: 60 minutes
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Reaction Time will be assessed during Stroop task
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60 minutes
|
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Accuracy performance Stroop Task
Tidsramme: 60 minutes
|
Accuracy will be assessed during Stroop task
|
60 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. februar 2021
Primær færdiggørelse (Forventet)
30. juni 2021
Studieafslutning (Forventet)
31. juli 2021
Datoer for studieregistrering
Først indsendt
22. september 2020
Først indsendt, der opfyldte QC-kriterier
19. januar 2021
Først opslået (Faktiske)
22. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MF-EEG-MRCP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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