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出境医 / 临床实验 / The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population

The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Physical Fatigue Return to Sport Injury Prevention EEG Brain Activity Balance Behavioral: Physical Fatigue Behavioral: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Influence of Acute Physical Fatigue on Different Balance Tests and Brain Activity During These Balance Tests in a Healthy Population
Actual Study Start Date : July 19, 2019
Actual Primary Completion Date : March 9, 2020
Actual Study Completion Date : March 9, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Physical Fatigue Condition Behavioral: Physical Fatigue
Maximal cycling effort for 30s (Wingate modified)

Placebo Comparator: Control Condition Behavioral: Control
time-matched task (sitting on the bike without pedalling)

Outcome Measures
Primary Outcome Measures :
  1. Y-balance test [ Time Frame: 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

  2. Balance-reaction time test [ Time Frame: 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.

  3. EEG power spectrum analysis [ Time Frame: 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.


Secondary Outcome Measures :
  1. Mental fatigue Visual Analogue Scale (M-VAS) [ Time Frame: 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) ]
    Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)

  2. Perception of effort (Session RPE) [ Time Frame: 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) ]
    Subjective measure of effort after completion of the test battery (scale from 0 to 10; 0 = very very easy; 10 = maximal effort)

  3. Self-reported motivation [ Time Frame: At baseline: prior to the first test battery ]
    Subjective measure of motivation assessed with the self-reported Motivation scale of Matthews et al.. (the questionnaire measures 2 constructs: intrinsic motivation and task succes motivation;the questionnaire comprises 14 questions scored from 0 to 4 [0 = not all motivated, while 4 = maximally motivated]. Each construct contains 7 questions).

  4. Blood lactate [ Time Frame: 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 ]
    Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)

  5. Blood glucose [ Time Frame: 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) ]
    Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration

  6. Blood pressure [ Time Frame: 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) ]
    Objective measure of blood pressure via eletronic blood pressure measuring device


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal 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 experimental trial
Contacts and Locations

Locations
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Belgium
Vrije Universiteit Brussel
Brussels, Belgium, 1050
Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
Layout table for investigator information
Principal Investigator: Romain Meeusen, Professor Vrije Universiteit Brussel
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE July 19, 2019
Actual Primary Completion Date March 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Y-balance test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Mental fatigue Visual Analogue Scale (M-VAS) [ Time Frame: 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) ]
    Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
  • Perception of effort (Session RPE) [ Time Frame: 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) ]
    Subjective measure of effort after completion of the test battery (scale from 0 to 10; 0 = very very easy; 10 = maximal effort)
  • Self-reported motivation [ Time Frame: At baseline: prior to the first test battery ]
    Subjective measure of motivation assessed with the self-reported Motivation scale of Matthews et al.. (the questionnaire measures 2 constructs: intrinsic motivation and task succes motivation;the questionnaire comprises 14 questions scored from 0 to 4 [0 = not all motivated, while 4 = maximally motivated]. Each construct contains 7 questions).
  • Blood lactate [ Time Frame: 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 ]
    Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)
  • Blood glucose [ Time Frame: 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) ]
    Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
  • Blood pressure [ Time Frame: 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) ]
    Objective measure of blood pressure via eletronic blood pressure measuring device
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population
Official Title  ICMJE The Influence of Acute Physical Fatigue on Different Balance Tests and Brain Activity During These Balance Tests in a Healthy Population
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Physical Fatigue
  • Return to Sport
  • Injury Prevention
  • EEG
  • Brain Activity
  • Balance
Intervention  ICMJE
  • Behavioral: Physical Fatigue
    Maximal cycling effort for 30s (Wingate modified)
  • Behavioral: Control
    time-matched task (sitting on the bike without pedalling)
Study Arms  ICMJE
  • Experimental: Physical Fatigue Condition
    Intervention: Behavioral: Physical Fatigue
  • Placebo Comparator: Control Condition
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 9, 2020
Actual Primary Completion Date March 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal 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 experimental trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04030390
Other Study ID Numbers  ICMJE 143201939780
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Romain Meeusen, Vrije Universiteit Brussel
Study Sponsor  ICMJE Vrije Universiteit Brussel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Romain Meeusen, Professor Vrije Universiteit Brussel
PRS Account Vrije Universiteit Brussel
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP