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

Primary Purpose

Mental Fatigue, Return to Sport, EEG

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mental Fatigue
Control
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mental Fatigue

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vrije Universiteit Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mental Fatigue Condition

Control Condition

Arm Description

Outcomes

Primary Outcome Measures

Single-leg hop test
Single-leg hop test for distance performance
Vertical jump test
Vertical jump height performance
Y-balance test
Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.
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.
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

Secondary Outcome Measures

Mental fatigue Visual Analogue Scale (M-VAS)
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
Flanker task
Objective measure of mental fatigue; reaction time and accuracy give an objective indication of mental fatigue
90-minute stroop task
90 minutes mental fatiguing task; reaction time and accuracy give an objective indication of mental fatigue

Full Information

First Posted
August 8, 2018
Last Updated
July 18, 2019
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03643406
Brief Title
The Effect of Mental Fatigue on Lower Limb Functional Performance Tests and Brain Activity in a Healthy Population
Official Title
The Influence of Acute Mental Fatigue on Functional Performance Tests of the Lower Limb and Brain Activity in a Healthy Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective of the study The main objectives of this project are: To assess the influence of mental fatigue on a return-to-play test battery in healthy population 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue, Return to Sport, EEG, Brain Activity, Functional Performance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mental Fatigue Condition
Arm Type
Experimental
Arm Title
Control Condition
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Mental Fatigue
Intervention Description
modified stroop task
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
documentary
Primary Outcome Measure Information:
Title
Single-leg hop test
Description
Single-leg hop test for distance performance
Time Frame
Change in single-leg hop test for distance performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Title
Vertical jump test
Description
Vertical jump height performance
Time Frame
Change in vertical jump height performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Title
Y-balance test
Description
Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.
Time Frame
Change in Y-balance performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Title
Balance-reaction time test
Description
Balance and reaction time performance; participants have to maintain their balance while reacting as fast as possible in 3 different directions.
Time Frame
Change in balance and reaction time performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Title
EEG power spectrum analysis
Description
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
Time Frame
Change in EEG power spectrum: from baseline and 120 minutes after baseline (immediately after the flanker task)
Secondary Outcome Measure Information:
Title
Mental fatigue Visual Analogue Scale (M-VAS)
Description
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
Time Frame
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)
Title
Flanker task
Description
Objective measure of mental fatigue; reaction time and accuracy give an objective indication of mental fatigue
Time Frame
Change in flanker task: at baseline and 90 minutes after baseline (immediately after the mental fatiguing task)
Title
90-minute stroop task
Description
90 minutes mental fatiguing task; reaction time and accuracy give an objective indication of mental fatigue
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1050
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
individual patient data will not be shared

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

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