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临床试验/NCT03643406
NCT03643406已完成不适用

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

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年10月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Single-leg hop test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • 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

研究组 & 干预措施

Control Condition

Placebo Comparator

干预措施: Control (Other)

Mental Fatigue Condition

Experimental

干预措施: Mental Fatigue (Other)

结局指标

主要结局

Single-leg hop test

时间窗: Change in single-leg hop test for distance performance: from baseline and 120 minutes after baseline (immediately after the flanker task)

Single-leg hop test for distance performance

Y-balance test

时间窗: Change in Y-balance performance: from baseline and 120 minutes after baseline (immediately after the flanker task)

Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.

Vertical jump test

时间窗: Change in vertical jump height performance: from baseline and 120 minutes after baseline (immediately after the flanker task)

Vertical jump height performance

EEG power spectrum analysis

时间窗: Change in EEG power spectrum: from baseline and 120 minutes after baseline (immediately after the flanker task)

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

Balance-reaction time test

时间窗: Change in balance and reaction time performance: from baseline and 120 minutes after baseline (immediately after the flanker task)

Balance and reaction time performance; participants have to maintain their balance while reacting as fast as possible in 3 different directions.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Romain Meeusen

Professor

Vrije Universiteit Brussel

研究点 (2)

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