The Effect of Mental Fatigue on Lower Limb Functional Performance Tests and Brain Activity in a Healthy Population

Mental Fatigue Clinical Trial

Official title:

The Influence of Acute Mental Fatigue on Functional Performance Tests of the Lower Limb and Brain Activity in a Healthy Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643406
• Other study ID #: 143201836625
• Status: Completed
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: July 2019
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective of the study

The main objectives of this project are:

1. To assess the influence of mental fatigue on a return-to-play test battery in healthy population

2. To assess the influence of mental fatigue on brain functioning during a balance and reaction time task in healthy population In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).

The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design.

Thirteen healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a mental fatigue scale (M-VAS) and motivation scale. Next, the subjects will carry out a functional test battery (hop test, vertical jump test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (RPE) is measured to indicate how fatigued the participants feel because of the test battery; also, M-VAS is collected once more. Then, a short cognitive task (Flanker task) is followed by either a long intensive cognitive task (90 minutes Stroop task) or control task (90 minutes documentary). Afterwards, participants have to carry out the Flanker task, fill in M-VAS (2x), perform the same test battery, fill in session RPE and one final fatigue scale (Nasa TLX). Heart frequency and EEG will be measured continuously during the trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 17, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy (No neurological/cardiorespiratory/psychological disorders)

• Male and female

• No medication

• Non-smoker

• Between 18 and 35 years old

Exclusion Criteria:

• Back and/or lower extremity injuries during the past 6 months

• Bone/joint abnormalities

• Dizziness, history of loss of consciousness, any inner ear disorders

• Nervous system disorders or dysfunctions

• Uncorrected eye disorders/dysfunctions

• Illness

• Use of medication or any kind of drugs

• Use of alcohol, caffeine and heavy efforts 24 hours before each trial

• Not eating the same meal the night before and the morning of each trial

Related Conditions & MeSH terms

• Brain Activity
• EEG
• Fatigue
• Functional Performance
• Mental Fatigue
• Return to Sport

Intervention

Other:
• Mental Fatigue
modified stroop task
• Control
documentary

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single-leg hop test	Single-leg hop test for distance performance	Change in single-leg hop test for distance performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Primary	Vertical jump test	Vertical jump height performance	Change in vertical jump height performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Primary	Y-balance test	Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.	Change in Y-balance performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Primary	Balance-reaction time test	Balance and reaction time performance; participants have to maintain their balance while reacting as fast as possible in 3 different directions.	Change in balance and reaction time performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Primary	EEG power spectrum analysis	Brain activity during the Y-balance test, balance-reaction time test and flanker task will be registered at baseline and immediately after the flanker task	Change in EEG power spectrum: from baseline and 120 minutes after baseline (immediately after the flanker task)
Secondary	Mental fatigue Visual Analogue Scale (M-VAS)	Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)	Change in M-VAS: at baseline, 20 min after baseline (immediately after the first test battery), 120 min after baseline (immediately after the second flanker task) and 135 min after baseline (immediately after the final test battery)
Secondary	Flanker task	Objective measure of mental fatigue; reaction time and accuracy give an objective indication of mental fatigue	Change in flanker task: at baseline and 90 minutes after baseline (immediately after the mental fatiguing task)
Secondary	90-minute stroop task	90 minutes mental fatiguing task; reaction time and accuracy give an objective indication of mental fatigue	Change in reaction time and accuracy will be assessed with a 90-min cognitive task; Reaction Time and Accuracy during the 90-min task will be reported as mean reaction time and accuracy during 8 blocks of 11min15sec