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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04719975
Other study ID # MF-EEG-MRCP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date July 31, 2021

Study information

Verified date January 2021
Source Vrije Universiteit Brussel
Contact Matthias Proost, MSc
Phone 026292753
Email matthias.proost@vub.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date July 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mental Fatigue (Stroop task)
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.
Control (Documentary)
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.

Locations

Country Name City State
Belgium Human Physiology and Sports Physiotherapy Research Group Brussel Elsene

Sponsors (1)

Lead Sponsor Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Reaction Time Flanker Task Reaction Time will be assessed during Flanker task Total of 10 minutes
Primary Accuracy Flanker Task Accuracy will be assessed during Flanker task Total of 10 minutes
Primary Reaction Time Stroop Task Reaction Time will be assessed during Stroop task 60 minutes
Primary Accuracy performance Stroop Task Accuracy will be assessed during Stroop task 60 minutes
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