Mental FatigueNCT04719975
The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
A study testing Mental Fatigue (Stroop task) in people with Mental Fatigue and Electroencephalography, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The purpose of this project is to provide further insights into the neurophysiology behind the MF-induced impairment in endurance performance. The aim is to perform a randomized controlled trial in which we partly replicate studies of Marcora et al. (2009) and Bigliassi et al. 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, Electroencephalography
- What is being tested?
- Mental Fatigue (Stroop task)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 31 Jul 2021
- 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 or cardiovascular disorders)
- Male or female
- No medication
- Non-smoker
- Between 18 and 35 years old
- Recreational athlete population (performance level 2 or 3 for men according to De Pauw et al. (2013) and performance level 2 or 3 for woman according to Decroix et al. (2016)
Who cannot join
- Injuries over the last 6 months
- Suffering from any cardiovascular condition
- Use of medication
- Suffering from other health conditions at the time of testing
- Use of caffeine or alcohol 24 hours prior to each trial
- Heavy efforts 24 hours prior to each trial
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Human Physiology and Sports Physiotherapy Research Group
Brussels, Elsene, 1050
About this study
The purpose of this project is to provide further insights into the neurophysiology behind the MF-induced impairment in endurance performance. The aim is to perform a randomized controlled trial in which we partly replicate studies of Marcora et al. (2009) and Bigliassi et al. (2017), while extensively monitoring brain activity during the entire protocol (i.e. both cognitive and physical tasks) by using EEG.
- Conditions
- Mental Fatigue, Electroencephalography
- Being tested
- Mental Fatigue (Stroop task), Control (Documentary)
- 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 Fatigue (Stroop task)Other
A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words ("rood", "blauw", "groen" and "geel") will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself.
Control (Documentary)Other
In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team. During the control task physiological and psychological measures will be assessed at the same time points as during the mental fatigue trial.
| Study group | Role | What they receive |
|---|---|---|
| Mental Fatigue (Stroop) - Chair task | Experimental | Participants will be performing the Chair Task (150 submaximal dynamic knee extensions at 50% of their maximal voluntary contraction (MVC)) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured. Receives: Other: Mental Fatigue (Stroop task) |
| Control Task (Documentary) - Chair Task | Placebo comparator | In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Chair Task, During the whole trial EEG will be measured. Receives: Other: Control (Documentary) |
| Mental Fatigue (Stroop) - Bike Task | Experimental | Participants will be performing the Bike Task (a 9 min cycling task performed at 45 rpm with intensity being constant and will be 10% below VT) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured. Receives: Other: Mental Fatigue (Stroop task) |
| Control task (Documentary) - Bike Task | Placebo comparator | In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Bike Task, During the whole trial EEG will be measured. Receives: Other: Control (Documentary) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram data
During whole of the trials EEG data will be gathered, each trial will last one and a half to two hours. EEG power in delta, theta, alpha, beta band.
Measured: 1 hours 30 minutes - 2 hours
Reaction Time Flanker Task
Reaction Time will be assessed during Flanker task
Measured: Total of 10 minutes
Accuracy Flanker Task
Accuracy will be assessed during Flanker task
Measured: Total of 10 minutes
Reaction Time Stroop Task
Reaction Time will be assessed during Stroop task
Measured: 60 minutes
Accuracy performance Stroop Task
Accuracy will be assessed during Stroop task
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Model description
- Randomized, blinded, counter-balanced, cross-over design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
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
- NCT04719975
- Sponsor's protocol ID
- MF-EEG-MRCP
- Status last verified
- Jan 2021
- First submitted
- 22 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Proost M, Habay J, DE Wachter J, DE Pauw K, Marusic U, Meeusen R, DE Bock S, Roelands B, VAN Cutsem J. The Impact of Mental Fatigue on a Strength Endurance Task: Is There a Role for the Movement-Related Cortical Potential? Med Sci Sports Exerc. 2024 Mar 1;56(3):435-445. doi: 10.1249/MSS.0000000000003322. Epub 2023 Oct 16.
PubMed 37847068
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Electrophysiological Signature of the Mental Fatigue-induced Impairment in Endurance Performance
- ClinicalTrials.gov ID
- NCT04719975
- Acronym / sponsor ID
- MF-EEG-MRCP
- Conditions
- Mental Fatigue, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 22 Jan 2021 (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.
The purpose of this project is to provide further insights into the neurophysiology behind the MF-induced impairment in endurance performance. The aim is to perform a randomized controlled trial in which we partly replicate studies of Marcora et al. (2009) and Bigliassi et al. (2017), while extensively monitoring brain activity during the entire protocol (i.e. both cognitive and physical tasks) by using EEG.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, blinded, counter-balanced, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Mental Fatigue (Stroop) - Chair task | Experimental | Other: Mental Fatigue (Stroop task)Participants will be performing the Chair Task (150 submaximal dynamic knee extensions at 50% of their maximal voluntary contraction (MVC)) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured. |
| Control Task (Documentary) - Chair Task | Placebo comparator | Other: Control (Documentary)In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Chair Task, During the whole trial EEG will be measured. |
| Mental Fatigue (Stroop) - Bike Task | Experimental | Other: Mental Fatigue (Stroop task)Participants will be performing the Bike Task (a 9 min cycling task performed at 45 rpm with intensity being constant and will be 10% below VT) when mentally fatigued. A 60 minute variant of the Stroop task will be used to induce the mental fatigue. During the whole trial EEG will be measured. |
| Control task (Documentary) - Bike Task | Placebo comparator | Other: Control (Documentary)In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content. This will be followed by the Bike Task, During the whole trial EEG will be measured. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy (No neurological or cardiovascular disorders)
- Male or female
- No medication
- Non-smoker
- Between 18 and 35 years old
Key exclusion criteria (6 listed)
- Injuries over the last 6 months
- Suffering from any cardiovascular condition
- Use of medication
- Suffering from other health conditions at the time of testing
- Use of caffeine or alcohol 24 hours prior to each trial
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 Fatigue (Stroop task)A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words ("rood", "blauw", "groen" and "geel") will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself. | Other | Mental Fatigue (Stroop) - Bike Task, Mental Fatigue (Stroop) - Chair task |
| Control (Documentary)In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team. During the control task physiological and psychological measures will be assessed at the same time points as during the mental fatigue trial. | Other | Control Task (Documentary) - Chair Task, Control task (Documentary) - Bike Task |
Primary outcome
Electroencephalogram data
Time frame: 1 hours 30 minutes - 2 hours
During whole of the trials EEG data will be gathered, each trial will last one and a half to two hours. EEG power in delta, theta, alpha, beta band.
Reaction Time Flanker Task
Time frame: Total of 10 minutes
Reaction Time will be assessed during Flanker task
Accuracy Flanker Task
Time frame: Total of 10 minutes
Accuracy will be assessed during Flanker task
Reaction Time Stroop Task
Time frame: 60 minutes
Reaction Time will be assessed during Stroop task
Accuracy performance Stroop Task
Time frame: 60 minutes
Accuracy will be assessed during Stroop task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 37847068Proost M, Habay J, DE Wachter J, DE Pauw K, Marusic U, Meeusen R, DE Bock S, Roelands B, VAN Cutsem J. The Impact of Mental Fatigue on a Strength Endurance Task: Is There a Role for the Movement-Related Cortical Potential? Med Sci Sports Exerc. 2024 Mar 1;56(3):435-445. doi: 10.1249/MSS.0000000000003322. Epub 2023 Oct 16.
- Individual participant dataSharing planned: No
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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.
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 (Stroop task) in people with Mental Fatigue and Electroencephalography, 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Proost, MSc (026292753, matthias.proost@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram data (time frame: 1 hours 30 minutes - 2 hours). 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?
On the ClinicalTrials.gov record for NCT04719975, which also lists 1 linked publication.
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 22 Jan 2021.