Clinical trial NCT05576935: The Individual Response of Healthy Individuals to Mental Fatigue
Official title: The Individual Response of Healthy Individuals to Mental Fatigue: a Randomized Crossover Trial Investigating the Influence of Internal Factors in the Effects of Mental Fatigue on Human Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Fatigue
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: R randomized, single-blinded, placebo controlled, counter-balanced, cross-over design
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Every participant will visit the lab a total of three times within a period of two weeks. In the first visit, they will undergo both a detailed screening as well as perform all intervention/control trial measures to familiarize themselves with the utilised equipment. This detailed screening entails, among other things, a maximal incremental exercise test, a cognitive test battery and multiple subjective questionnaires.

The experimental and control trial are almost identical, with the only difference being the task performed in the middel of the trial. At the beginning of the trial the EEG will be fitted to the head of the participant and baseline measures will be taken. Afterwards, participants will perform a go nogo task to assess baseline cognitive performance. Then the intervention (i.e. Stroop task) or control (i.e. documentary) task will be performed. The goal of the Stroop task is to elicit mental fatigue, while the documentary provides a meaningful comparison. Afterwards, cognitive performance will again be assessed using the go no go task, followed by a physical performance task in the form of a time trial.

The different internal factors assessed during the screening stage will be correlated to the difference in cognitive and physical performance between the intervention and control trial.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Physical performance
timeFrame: through study completion, an average of 2 years
measure: Cognitive performance: Go NoGo task: attention
timeFrame: through study completion, an average of 2 years
measure: Cognitive performance: Go NoGo task: response inhibition
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Subjective Manipulation check: M-VAS
timeFrame: through study completion, an average of 2 years
measure: Behavioural Manipulation check: Stroop reaction time
timeFrame: through study completion, an average of 2 years
measure: Behavioural Manipulation check: Stroop accuracy
timeFrame: through study completion, an average of 2 years
measure: Physiological manipulation check - EEG (theta and alpha power and ERPs)
timeFrame: through study completion, an average of 2 years
measure: Age
timeFrame: through study completion, an average of 2 years
measure: Length
timeFrame: through study completion, an average of 2 years
measure: Weight
timeFrame: through study completion, an average of 2 years
measure: Sex
timeFrame: through study completion, an average of 2 years
measure: Fat percentage
timeFrame: through study completion, an average of 2 years
measure: Burn out
timeFrame: through study completion, an average of 2 years
measure: Recovery need
timeFrame: through study completion, an average of 2 years
measure: Physical training level (objective)
timeFrame: through study completion, an average of 2 years
measure: Physical training level (subjective)
timeFrame: through study completion, an average of 2 years
measure: Sport participation
timeFrame: through study completion, an average of 2 years
measure: Working memory
timeFrame: through study completion, an average of 2 years
measure: Response inhibition
timeFrame: through study completion, an average of 2 years
measure: Attention
timeFrame: through study completion, an average of 2 years
measure: Genetics
timeFrame: through study completion, an average of 2 years
measure: Sleep quality
timeFrame: through study completion, an average of 2 years
measure: Chronotype
timeFrame: through study completion, an average of 2 years
measure: Trait Self control
timeFrame: through study completion, an average of 2 years
measure: Trait Anxiety
timeFrame: through study completion, an average of 2 years
measure: Mental Toughness
timeFrame: through study completion, an average of 2 years
measure: Caffeine use
timeFrame: through study completion, an average of 2 years
Other outcomes:
measure: Mental workload: NASA-TLX 4
timeFrame: through study completion, an average of 2 years
measure: Motivation: Moti-VAS
timeFrame: through study completion, an average of 2 years
measure: Mood: BRUMS
timeFrame: through study completion, an average of 2 years
measure: Subjective physical fatigue: P-VAS
timeFrame: through study completion, an average of 2 years
measure: Sleepiness: Karolinska
timeFrame: through study completion, an average of 2 years
measure: Subjective feelings of boredom: B-VAS
timeFrame: through study completion, an average of 2 years
measure: Internal load
timeFrame: through study completion, an average of 2 years
measure: Glucose concentration (mmol/l)
timeFrame: through study completion, an average of 2 years
measure: Heart rate
timeFrame: through study completion, an average of 2 years
measure: Lactate concentration (mmol/l)
timeFrame: through study completion, an average of 2 years
Locations:
city: Etterbeek
country: Belgium
facility: BLITS-Brussels Labo voor Inspanning en Topsport
state: Brussel
Study officials:
References:
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