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

NCT03643406 | Completed

• 1 other identifier: 143201836625
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Objective of the study The main objectives of this project are:

1. 1.To assess the influence of mental fatigue on a return-to-play test battery in healthy population
2. 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).

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Mental fatigue Visual Analogue Scale (M-VAS)

  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

  Change in flanker task: at baseline and 90 minutes after baseline (immediately after the mental fatiguing task)

• 90-minute stroop task

  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

Study Arms (2)

Mental Fatigue Condition

EXPERIMENTAL

Other: Mental Fatigue

Control Condition

PLACEBO COMPARATOR

Other: Control

Interventions

Mental Fatigue OTHER

modified stroop task

Mental Fatigue Condition

Control OTHER

documentary

Control Condition

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (No neurological/cardiorespiratory/psychological disorders)
• Male and female
• No medication
• Non-smoker
• Between 18 and 35 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 22, 2018
• Study Start: October 19, 2018
• Primary Completion: July 16, 2019
• Study Completion: July 17, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)