The Individual Response of Healthy Individuals to Mental Fatigue

NCT05576935 | Completed

• 1 other identifier: 1432022000084
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to confirm and map out the presence of interindividual differences in the effect of mental fatigue on both physical and cognitive performance, and to see if these differences are related to individual factors of the participants.

Conditions

Mental Fatigue

Outcome Measures

Primary Outcomes (3)

• Physical performance

  Participants will perform a time trial to assess physical performance. Participants will be able to start a 3 min fixed intensity warm-up. The trial itself lasts 15 min and participants are instructed to cover as much distance as possible. To keep the influence of motivation to a minimum, no encouragements or performance feedback will be given during the trial. The participants will only see the amount of time they have left on a digital chronometer. After the trial, a 2 min self-paced cooldown period will start. The evaluted outcome will be total workload performed by the participants (in kJ).

  through study completion, an average of 2 years

• Cognitive performance: Go NoGo task: attention

  Cognitive performance will be assessed using a task based on the go/no-go paradigm. Participants are to react to different stimuli displayed on a computer screen positioned about 1 meter from the subject, preceded by a screen with general instructions. Two different stimuli were present at the same time: a Go or NoGo stimuli, and a left or right stimuli (meaning that four combinations are possible: GoRight, GoLeft, NoGoRight and NoGoLeft). If a Go stimuli is presented, participants are instructed to react to the left or right stimuli with the corresponding arrows. However, if a NoGo stimulus is presented, participants are instructed to refrain from reacting to the either the left or right stimuli. This proposed paradigm measures attention, response inhibition and working memory. Stimuli will be presented for 500 ms, with a varying interstimulus time between 1100 and 1700 ms. Outcome for attention will be reaction time on the Go trials.

  through study completion, an average of 2 years

• Cognitive performance: Go NoGo task: response inhibition

  Cognitive performance will be assessed using a task based on the go/no-go paradigm. Participants are to react to different stimuli displayed on a computer screen positioned about 1 meter from the subject, preceded by a screen with general instructions. Two different stimuli were present at the same time: a Go or NoGo stimuli, and a left or right stimuli (meaning that four combinations are possible: GoRight, GoLeft, NoGoRight and NoGoLeft). If a Go stimuli is presented, participants are instructed to react to the left or right stimuli with the corresponding arrows. However, if a NoGo stimulus is presented, participants are instructed to refrain from reacting to the either the left or right stimuli. This proposed paradigm measures attention, response inhibition and working memory. Stimuli will be presented for 500 ms, with a varying interstimulus time between 1100 and 1700 ms. Outcome for response inhibition will be accuracy on the NoGo trials.

  through study completion, an average of 2 years

Secondary Outcomes (24)

• Subjective Manipulation check: M-VAS

  through study completion, an average of 2 years

• Behavioural Manipulation check: Stroop reaction time

  through study completion, an average of 2 years

• Behavioural Manipulation check: Stroop accuracy

  through study completion, an average of 2 years

• Physiological manipulation check - EEG (theta and alpha power and ERPs)

  through study completion, an average of 2 years

• Age

  through study completion, an average of 2 years

Other Outcomes (10)

• Mental workload: NASA-TLX 4

  through study completion, an average of 2 years

• Motivation: Moti-VAS

  through study completion, an average of 2 years

• Mood: BRUMS

  through study completion, an average of 2 years

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention task consists of a 60 minute Stroop task. In this task, four coloured 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 colour of the word, ignoring the meaning of the word itself. If, however, the ink colour of the word is red, the button to be pressed will be the button linked to the real meaning of the word. The word presented and its ink colour will be randomly selected by a computer (100% incongruent), with all incongruent word-colour combinations being equally common. Subjects will be instructed to respond as quickly and accurately as possible. To assess performance both ACC and reaction time (RT) will be collected and averaged every block.

Behavioral: Stroop task

Control

ACTIVE COMPARATOR

In the control task subjects will have to watch a documentary of 60 min.

Behavioral: Documentary

Interventions

Stroop task BEHAVIORAL

The task is partitioned in 4 blocks of 360 stimuli and each word will be presented on screen in 34 point font for 1000 ms with an inter-stimulus interval based on their performance on the Stroop max test. This max test will be performed during the familiarization trial, and is divided in blocks of 96 stimuli. After each block, the accuracy (ACC) will be calculated. When ACC \> 85%, the difficulty of the Stroop task will be increased by decreasing the stimulus presentation time (SPT). If ACC \< 85%, this block will be considered as an 'error' and the subject must redo the block without changing the SPT. The first block will have a SPT of 1500 ms. When the required ACC is achieved, the SPT will decrease in the following order: 1100, 900, 800,… to determine the individualized cognitive load. When the subject makes 3 errors in a row, or 5 errors during the whole trial, the trial will end. The SPT of the last block will be considered as the maximum capacity of that individual.

Intervention

Documentary BEHAVIORAL

In order to avoid under- and over-arousal, participants will have the opportunity to choose between several documentaries. The participants will also receive a list of the available documentaries (based on selections from Netflix and Disney+) after the familiarization trial so that the trial can go as smoothly as possible.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (No neurological, cardiovascular or musculoskeletal disorders of any kind)
• No prior knowledge of the concept of mental fatigue
• No medication
• Non-smoker

You may not qualify if:

• Injuries of any kind in the past 6 months
• Suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal)
• Participating in any concomitant care or research trials
• History of suffering from any mental/psychiatric disorders
• Suffering from a higher risk of burn out, indicated by a total score of ≥ 2.59 on the Burn out assessment tool (BAT)
• Suffering from high general fatigue, indicated by a score of \>59 on the Multidimensional fatigue inventory (MFI)
• Suffering from depression, indicated by a score of \>16 on the Beck depression inventory-II (BDI-II)
• Use of medication
• Use of caffeine and heavy efforts 24 hours prior each trial
• Suffering from colour vision deficiencies
• Not eating a standardized meal, the morning of each trial

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

BLITS-Brussels Labo voor Inspanning en Topsport

Etterbeek, Brussels Capital, 1050, Belgium

Location

Related Publications (5)

• De Pauw K, Roelands B, Cheung SS, de Geus B, Rietjens G, Meeusen R. Guidelines to classify subject groups in sport-science research. Int J Sports Physiol Perform. 2013 Mar;8(2):111-22. doi: 10.1123/ijspp.8.2.111.

  PMID: 23428482 BACKGROUND

• Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.

  PMID: 2062970 BACKGROUND

• Hernandez R, Roll SC, Jin H, Schneider S, Pyatak EA. Validation of the National Aeronautics and Space Administration Task Load Index (NASA-TLX) adapted for the whole day repeated measures context. Ergonomics. 2022 Jul;65(7):960-975. doi: 10.1080/00140139.2021.2006317. Epub 2021 Nov 22.

  PMID: 34766872 BACKGROUND

• Kaida K, Takahashi M, Akerstedt T, Nakata A, Otsuka Y, Haratani T, Fukasawa K. Validation of the Karolinska sleepiness scale against performance and EEG variables. Clin Neurophysiol. 2006 Jul;117(7):1574-81. doi: 10.1016/j.clinph.2006.03.011. Epub 2006 May 6.

  PMID: 16679057 BACKGROUND

• Habay J, Arenales Arauz YL, Proost M, Schampheleer E, Lathouwers E, De Pauw K, Pattyn N, Van Cutsem J, Roelands B. Mental Fatigue Negatively Impacts Cognitive and Physical Performance Outcomes: A Large-Scale Randomized Crossover Trial. Med Sci Sports Exerc. 2026 Feb 1;58(2):225-241. doi: 10.1249/MSS.0000000000003852. Epub 2025 Sep 8.

  PMID: 40938104 DERIVED

MeSH Terms

Conditions

Mental Fatigue

Interventions

Stroop Test

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not informed as to what condition they are subjected.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: R randomized, single-blinded, placebo controlled, counter-balanced, cross-over design

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: October 13, 2022
• Study Start: July 1, 2022
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will become available on request as soon as the study ends. Data can be requested for at least 10 years after the end of the study.

Locations

BE (1)