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

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Fatigue; Return to Sport; EEG; Brain Activity; Functional Performance
• Intervention / Treatment: Other: Mental Fatigue; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1050
    • Vrije Universiteit Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mental Fatigue Condition	Other: Mental Fatigue; modified stroop task
Placebo Comparator: Control Condition	Other: Control; documentary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Actual): July 16, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue
• Other Study ID Numbers: 143201836625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: individual patient data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No