Mental FatigueNCT03643406
The Effect of Mental Fatigue on Lower Limb Functional Performance Tests and Brain Activity in a Healthy Population
A study testing Mental Fatigue in people with Mental Fatigue and Return to Sport, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Return to Sport, EEG
- What is being tested?
- Mental Fatigue
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Oct 2018to 17 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (No neurological/cardiorespiratory/psychological disorders)
- Male and female
- No medication
- Non-smoker
- Between 18 and 35 years old
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Acute Mental Fatigue on Functional Performance Tests of the Lower Limb and Brain Activity in a Healthy Population
Objective of the study
The main objectives of this project are:
Read more
- 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.
- Conditions
- Mental Fatigue, Return to Sport, EEG, Brain Activity, Functional Performance
- Being tested
- Mental Fatigue, Control
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental FatigueOther
modified stroop task
ControlOther
documentary
| Study group | Role | What they receive |
|---|---|---|
| Mental Fatigue Condition | Experimental | Not described Receives: Other: Mental Fatigue |
| Control Condition | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-leg hop test
Single-leg hop test for distance performance
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
Measured: 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
Objective measure of mental fatigue; reaction time and accuracy give an objective indication of mental fatigue
Measured: Change in flanker task: at baseline and 90 minutes after baseline (immediately after the mental fatiguing task)
90-minute stroop task
90 minutes mental fatiguing task; reaction time and accuracy give an objective indication of mental fatigue
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start19 Oct 2018
- Primary completion16 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643406
- Sponsor's protocol ID
- 143201836625
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual patient data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Acute Mental Fatigue on Functional Performance Tests of the Lower Limb and Brain Activity in a Healthy Population
- ClinicalTrials.gov ID
- NCT03643406
- Acronym / sponsor ID
- 143201836625
- Conditions
- Mental Fatigue, Return to Sport, EEG, Brain Activity, Functional Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Fatigue Condition | Experimental | Other: Mental Fatigue |
| Control Condition | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy (No neurological/cardiorespiratory/psychological disorders)
- Male and female
- No medication
- Non-smoker
- Between 18 and 35 years old
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Fatiguemodified stroop task | Other | Mental Fatigue Condition |
| Controldocumentary | Other | Control Condition |
Primary outcome
Single-leg hop test
Time frame: 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
Vertical jump test
Time frame: Change in vertical jump height performance: from baseline and 120 minutes after baseline (immediately after the flanker task)
Vertical jump height performance
Y-balance test
Time frame: 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.
Balance-reaction time test
Time frame: 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.
EEG power spectrum analysis
Time frame: 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
3 secondary outcomes
Mental fatigue Visual Analogue Scale (M-VAS)
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)
Flanker task
Time frame: Change in flanker task: at baseline and 90 minutes after baseline (immediately after the mental fatiguing task)
90-minute stroop task
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Individual participant dataSharing planned: No. individual patient data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Fatigue in people with Mental Fatigue and Return to Sport, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-leg hop test (time frame: Change in single-leg hop test for distance performance: from baseline and 120 minutes after baseline (immediately after the flanker task)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.