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临床试验/NCT04030390
NCT04030390已完成不适用

The Influence of Acute Physical Fatigue on Different Balance Tests and Brain Activity During These Balance Tests in a Healthy Population

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Y-balance test

研究概览

简要总结

The main objective of this project is:

  1. To assess the influence of physical fatigue on brain functioning during a balance and reaction time task in a 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. Twenty 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 pre-test checklist, a mental fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked.

Next, the subjects will carry out a Y-balance test and a balance reaction-time test. Session rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in M-VAS (2x), perform the same Y-balance test and balance reaction time test, and fill in the SRPE scale one more time. 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
Prevention
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/musculoskeletal 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 experimental trial

结局指标

主要结局

Y-balance test

时间窗: Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)

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

Balance-reaction time test

时间窗: Change in balance and reaction time performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)

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

时间窗: Change in EEG power spectrum: from baseline and 20 minutes after baseline (immediately after the assigned interventions)

Brain activity during the Y-balance test and balance-reaction time test will be registered at baseline and immediately after the assigned interventions.

次要结局

  • Mental fatigue Visual Analogue Scale (M-VAS)(Change in M-VAS: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final 2 balance tests))
  • Perception of effort (Session RPE)(Change in session RPE: at baseline (immediately after the first two balance tests), and 15 min after baseline (immediately after the final 2 balance tests))
  • Self-reported motivation(At baseline: prior to the first test battery)
  • Blood lactate(Blood lactate changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
  • Blood glucose(Blood glucose changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests))
  • Blood pressure(Blood pressure change: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests))

研究者

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

Romain Meeusen

Professor Dr.

Vrije Universiteit Brussel

研究点 (2)

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