- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04719975
The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
19 januari 2021 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
25
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Elsene
-
Brussel, Elsene, Belgien, 1050
- Human Physiology and Sports Physiotherapy Research Group
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 35 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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-jämförare: 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.
|
|
Experimentell: 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-jämförare: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Electroencephalogram data
Tidsram: 1 hours 30 minutes - 2 hours
|
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
Tidsram: Total of 10 minutes
|
Reaction Time will be assessed during Flanker task
|
Total of 10 minutes
|
|
Accuracy Flanker Task
Tidsram: Total of 10 minutes
|
Accuracy will be assessed during Flanker task
|
Total of 10 minutes
|
|
Reaction Time Stroop Task
Tidsram: 60 minutes
|
Reaction Time will be assessed during Stroop task
|
60 minutes
|
|
Accuracy performance Stroop Task
Tidsram: 60 minutes
|
Accuracy will be assessed during Stroop task
|
60 minutes
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 februari 2021
Primärt slutförande (Förväntat)
30 juni 2021
Avslutad studie (Förväntat)
31 juli 2021
Studieregistreringsdatum
Först inskickad
22 september 2020
Först inskickad som uppfyllde QC-kriterierna
19 januari 2021
Första postat (Faktisk)
22 januari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MF-EEG-MRCP
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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