Mental FatigueNCT07846618
Acute Mental Fatigue and Muscle Strength
A study testing Computer-Based Mental Fatigue Protocol in people with Mental Fatigue and Muscle Strength Dynamometer, run by Florida Institute for Human and Machine Cognition at 1 site in United States.
Trial summary
This study will investigate the acute effects of mental fatigue on lower-extremity muscle strength and limb symmetry in healthy young adults. Participants will complete lower-extremity strength testing before and after a standardized computer-based mental fatigue protocol involving tasks of attention, reaction time… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Muscle Strength Dynamometer
- What is being tested?
- Computer-Based Mental Fatigue Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-39 years
- Able to produce maximal force against Biodex protocol
- Able to perform required lower extremity movements through range of motion necessary for Biodex protocol
- No known cognitive impairment
- Sufficient musculoskeletal health to complete the tasks
Who cannot join
- History of a neurological disorder, disease, or cognitive impairment that may affect cognition, motor control, reaction time, or force production
- History of musculoskeletal injury affecting the lower extremities within the past 6 months
- History of lower extremity surgery affecting force production of the hip, knee, or ankle
- Color-vision impairment
- Significant visual or hearing impairment
- History of migraine headaches
Show all 16Show fewer
- Current significant sleep disturbances or sleep deprivation
- Head injury that may affect cognitive function
- Medical condition affecting ability to produce maximal force safely
- Allergy to adhesive tape, parabens, or propylene glycol
- Scalp lacerations, open wounds, or sutures on the scalp
- Cranial surgery or skull defects
- History of unexplained dizziness or fainting in the past 6 months
- Individuals who are pregnant, prisoners, or not yet adults
- Inability to communicate with investigators
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida Institute for Human and Machine Cognition
Pensacola, Florida, 32502
Nicole Rendos, PhD, 850-202-4442, nrendos@ihmc.org
About this study
Official title: Influence of Acute Mental Fatigue on Muscle Strength and Limb Symmetry in Healthy Adults
This study will investigate the acute effects of mental fatigue on lower-extremity muscle strength and limb symmetry in healthy young adults. Participants will complete lower-extremity strength testing before and after a standardized computer-based mental fatigue protocol involving tasks of attention, reaction time, concentration, and working memory. Muscle strength and limb symmetry will be assessed using isokinetic dynamometry, with muscle activity measured using surface electromyography. Participants will also complete subjective measures of mental fatigue, sleepiness, mental effort, and perceived physical exertion. Heart rate will be monitored throughout the study, and brain activity may be assessed during cognitive tasks. The study will determine whether acute mental fatigue is associated with changes in muscle strength, limb symmetry, and neuromuscular performance.
Read the detailed description
This study will investigate the acute effects of mental fatigue on lower-extremity muscle strength, interlimb symmetry, and neuromuscular performance in healthy young adults. The study will use a within-subject, repeated-measures design in which participants complete lower-extremity strength testing immediately before and after a standardized computer-based mental fatigue protocol. Each participant's pre-fatigue measurements will serve as the baseline comparison for their post-fatigue measurements.
Participants will complete one experimental session lasting up to approximately two hours at the Florida Institute for Human and Machine Cognition (IHMC) Healthspan, Resilience, and Performance Research Complex. Before testing, participants will undergo eligibility screening, provide written informed consent, and complete familiarization with the strength-testing procedures and computer-based cognitive tasks. Following familiarization, participants will complete a standardized rest period of at least five minutes before baseline measurements are collected.
Lower-extremity muscle strength will be assessed using a Biodex isokinetic dynamometer. Participants will perform knee extension and flexion with both lower extremities at three different movement speeds to assess strength across multiple testing conditions. Peak torque will be used as a primary measure of muscle strength. Testing of both limbs will also allow calculation of a Limb Symmetry Index (LSI) to quantify differences in strength between the lower extremities. Participants will rate their perceived physical exertion following each strength assessment.
Surface electromyography (EMG) will be used to record muscle activity from selected muscles of both thighs during strength testing. Participants may also perform maximal voluntary isometric contractions before the primary strength assessment to assist with normalization and interpretation of EMG signals. EMG measurements will be used to examine whether changes in strength following the mental fatigue protocol are accompanied by changes in muscle activity.
Following the baseline strength assessment, participants will complete approximately 30 minutes of standardized computer-based cognitive tasks designed to require sustained attention, concentration, reaction time, working memory, and mental effort and thereby induce acute mental fatigue. Tasks may include a psychomotor vigilance task, an incongruent Stroop task, and an n-back working-memory task. Reaction time and response accuracy may be recorded during the cognitive tasks.
Subjective mental fatigue and sleepiness will be assessed before and after the mental fatigue protocol. Following the cognitive tasks, participants will also rate the mental effort required to complete the tasks. These measures will be used to characterize the subjective response to the mental fatigue protocol and evaluate whether participants experienced increased mental fatigue following the intervention.
Heart rate and cardiac activity may be continuously monitored using a Polar H10 chest sensor during the experimental session to provide additional information regarding physiological responses during the strength-testing and cognitive-task portions of the protocol. Brain electrical activity may also be recorded using noninvasive electroencephalography (EEG) during the cognitive tasks in a subset of participants.
Immediately following completion of the mental fatigue protocol and post-task questionnaires, participants will repeat the same bilateral Biodex strength assessment performed at baseline. Testing procedures, positioning, movement speeds, instructions, and outcome measurements will be kept consistent between the pre- and post-fatigue assessments. Surface EMG will again be recorded during strength testing, and participants will rate their perceived physical exertion.
The primary analyses will compare pre- and post-fatigue measures of lower-extremity muscle strength and limb symmetry to determine whether acute mental fatigue is associated with changes in peak torque or LSI. Additional analyses will examine subjective mental fatigue, sleepiness, mental effort, perceived physical exertion, muscle activity, cognitive-task performance, and physiological responses. The findings will help determine whether acute mental fatigue should be considered when measuring and interpreting lower-extremity strength and limb symmetry in research, rehabilitation, and human performance settings.
- Conditions
- Mental Fatigue, Muscle Strength Dynamometer
- Being tested
- Computer-Based Mental Fatigue Protocol
- Keywords
- mental fatigue, muscle strength, limb symmetry, isokinetic dynamometry, electromyography
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Based Mental Fatigue ProtocolOther
Participants will complete approximately 30 minutes of standardized computer-based cognitive tasks designed to induce acute mental fatigue. The tasks require sustained attention, concentration, reaction time, working memory, and mental effort and may include the Psychomotor Vigilance Task (PVT), incongruent Stroop task, and n-back task. Participants will complete the mental fatigue protocol after baseline strength testing and before the post-intervention strength assessment. Subjective mental fatigue and sleepiness will be assessed before and after the intervention, and perceived mental effort will be assessed following the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mental Fatigue Intervention | Experimental | Participants will complete baseline lower-extremity muscle strength testing followed by approximately 30 minutes of standardized computer-based cognitive tasks designed to induce acute mental fatigue. Lower-extremity muscle strength testing will then be repeated immediately following the mental fatigue intervention. Receives: Other: Computer-Based Mental Fatigue Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-Extremity Muscle Strength
Lower-extremity muscle strength will be assessed using a Biodex isokinetic dynamometer during bilateral knee extension and flexion at three different movement speeds. Peak torque will be recorded as the primary measure of muscle strength. Changes in peak torque from baseline to immediately following the computer-based mental fatigue intervention will be evaluated.
Measured: Baseline and immediately following the approximately 30-minute mental fatigue intervention, during a single study visit lasting up to 2 hours.
Lower-Extremity Limb Symmetry
Limb symmetry will be assessed using peak torque measurements obtained from both lower extremities during isokinetic knee extension and flexion testing. A Limb Symmetry Index (LSI) will be calculated to quantify the similarity in muscle strength between the two lower extremities. Changes in LSI from baseline to immediately following the computer-based mental fatigue intervention will be evaluated.
Measured: Baseline and immediately following the approximately 30-minute mental fatigue intervention, during a single study visit lasting up to 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start23 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group, within-subject, pre-post repeated-measures study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Institute for Human and Machine Cognition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Rendos, Florida Institute for Human and Machine Cognition
- Investigators
- Nicole K Rendos, PhD, Principal investigator, Florida Institute for Human and Machine Cognition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846618
- Sponsor's protocol ID
- IRB-2026-0026
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications from this study may be made available to other researchers for scientific research purposes. Data will be shared without information that directly identifies participants.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Acute Mental Fatigue on Muscle Strength and Limb Symmetry in Healthy Adults
- ClinicalTrials.gov ID
- NCT07846618
- Acronym / sponsor ID
- IRB-2026-0026
- Conditions
- Mental Fatigue, Muscle Strength Dynamometer
- Keywords
- mental fatigue, muscle strength, limb symmetry, isokinetic dynamometry, electromyography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Florida Institute for Human and Machine CognitionUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
This study will investigate the acute effects of mental fatigue on lower-extremity muscle strength and limb symmetry in healthy young adults. Participants will complete lower-extremity strength testing before and after a standardized computer-based mental fatigue protocol involving tasks of attention, reaction time, concentration, and working memory. Muscle strength and limb symmetry will be assessed using isokinetic dynamometry, with muscle activity measured using surface electromyography. Participants will also complete subjective measures of mental fatigue, sleepiness, mental effort, and perceived physical exertion. Heart rate will be monitored throughout the study, and brain activity may be assessed during cognitive tasks. The study will determine whether acute mental fatigue is associated with changes in muscle strength, limb symmetry, and neuromuscular performance.
Detailed description
This study will investigate the acute effects of mental fatigue on lower-extremity muscle strength, interlimb symmetry, and neuromuscular performance in healthy young adults. The study will use a within-subject, repeated-measures design in which participants complete lower-extremity strength testing immediately before and after a standardized computer-based mental fatigue protocol. Each participant's pre-fatigue measurements will serve as the baseline comparison for their post-fatigue measurements.
Participants will complete one experimental session lasting up to approximately two hours at the Florida Institute for Human and Machine Cognition (IHMC) Healthspan, Resilience, and Performance Research Complex. Before testing, participants will undergo eligibility screening, provide written informed consent, and complete familiarization with the strength-testing procedures and computer-based cognitive tasks. Following familiarization, participants will complete a standardized rest period of at least five minutes before baseline measurements are collected.
Lower-extremity muscle strength will be assessed using a Biodex isokinetic dynamometer. Participants will perform knee extension and flexion with both lower extremities at three different movement speeds to assess strength across multiple testing conditions. Peak torque will be used as a primary measure of muscle strength. Testing of both limbs will also allow calculation of a Limb Symmetry Index (LSI) to quantify differences in strength between the lower extremities. Participants will rate their perceived physical exertion following each strength assessment.
Surface electromyography (EMG) will be used to record muscle activity from selected muscles of both thighs during strength testing. Participants may also perform maximal voluntary isometric contractions before the primary strength assessment to assist with normalization and interpretation of EMG signals. EMG measurements will be used to examine whether changes in strength following the mental fatigue protocol are accompanied by changes in muscle activity.
Following the baseline strength assessment, participants will complete approximately 30 minutes of standardized computer-based cognitive tasks designed to require sustained attention, concentration, reaction time, working memory, and mental effort and thereby induce acute mental fatigue. Tasks may include a psychomotor vigilance task, an incongruent Stroop task, and an n-back working-memory task. Reaction time and response accuracy may be recorded during the cognitive tasks.
Subjective mental fatigue and sleepiness will be assessed before and after the mental fatigue protocol. Following the cognitive tasks, participants will also rate the mental effort required to complete the tasks. These measures will be used to characterize the subjective response to the mental fatigue protocol and evaluate whether participants experienced increased mental fatigue following the intervention.
Heart rate and cardiac activity may be continuously monitored using a Polar H10 chest sensor during the experimental session to provide additional information regarding physiological responses during the strength-testing and cognitive-task portions of the protocol. Brain electrical activity may also be recorded using noninvasive electroencephalography (EEG) during the cognitive tasks in a subset of participants.
Immediately following completion of the mental fatigue protocol and post-task questionnaires, participants will repeat the same bilateral Biodex strength assessment performed at baseline. Testing procedures, positioning, movement speeds, instructions, and outcome measurements will be kept consistent between the pre- and post-fatigue assessments. Surface EMG will again be recorded during strength testing, and participants will rate their perceived physical exertion.
The primary analyses will compare pre- and post-fatigue measures of lower-extremity muscle strength and limb symmetry to determine whether acute mental fatigue is associated with changes in peak torque or LSI. Additional analyses will examine subjective mental fatigue, sleepiness, mental effort, perceived physical exertion, muscle activity, cognitive-task performance, and physiological responses. The findings will help determine whether acute mental fatigue should be considered when measuring and interpreting lower-extremity strength and limb symmetry in research, rehabilitation, and human performance settings.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group, within-subject, pre-post repeated-measures study
| Arm | Type | Receives |
|---|---|---|
| Mental Fatigue Intervention | Experimental | Other: Computer-Based Mental Fatigue ProtocolParticipants will complete baseline lower-extremity muscle strength testing followed by approximately 30 minutes of standardized computer-based cognitive tasks designed to induce acute mental fatigue. Lower-extremity muscle strength testing will then be repeated immediately following the mental fatigue intervention. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-39 years
- Able to produce maximal force against Biodex protocol
- Able to perform required lower extremity movements through range of motion necessary for Biodex protocol
- No known cognitive impairment
- Sufficient musculoskeletal health to complete the tasks
Key exclusion criteria (16 listed)
- History of a neurological disorder, disease, or cognitive impairment that may affect cognition, motor control, reaction time, or force production
- History of musculoskeletal injury affecting the lower extremities within the past 6 months
- History of lower extremity surgery affecting force production of the hip, knee, or ankle
- Color-vision impairment
- Significant visual or hearing impairment
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 |
|---|---|---|
| Computer-Based Mental Fatigue ProtocolParticipants will complete approximately 30 minutes of standardized computer-based cognitive tasks designed to induce acute mental fatigue. The tasks require sustained attention, concentration, reaction time, working memory, and mental effort and may include the Psychomotor Vigilance Task (PVT), incongruent Stroop task, and n-back task. Participants will complete the mental fatigue protocol after baseline strength testing and before the post-intervention strength assessment. Subjective mental fatigue and sleepiness will be assessed before and after the intervention, and perceived mental effort will be assessed following the intervention. | Other | Mental Fatigue Intervention |
Primary outcome
Lower-Extremity Muscle Strength
Time frame: Baseline and immediately following the approximately 30-minute mental fatigue intervention, during a single study visit lasting up to 2 hours.
Lower-extremity muscle strength will be assessed using a Biodex isokinetic dynamometer during bilateral knee extension and flexion at three different movement speeds. Peak torque will be recorded as the primary measure of muscle strength. Changes in peak torque from baseline to immediately following the computer-based mental fatigue intervention will be evaluated.
Lower-Extremity Limb Symmetry
Time frame: Baseline and immediately following the approximately 30-minute mental fatigue intervention, during a single study visit lasting up to 2 hours.
Limb symmetry will be assessed using peak torque measurements obtained from both lower extremities during isokinetic knee extension and flexion testing. A Limb Symmetry Index (LSI) will be calculated to quantify the similarity in muscle strength between the two lower extremities. Changes in LSI from baseline to immediately following the computer-based mental fatigue intervention will be evaluated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications from this study may be made available to other researchers for scientific research purposes. Data will be shared without information that directly identifies participants.
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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.
Nicole K Rendos, PhD principal investigator
Florida Institute for Human and Machine Cognition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Based Mental Fatigue Protocol in people with Mental Fatigue and Muscle Strength Dynamometer, run by Florida Institute for Human and Machine Cognition at 1 site in United States.
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 16 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole K Rendos, PhD (850-202-4442, nrendos@ihmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower-Extremity Muscle Strength (time frame: Baseline and immediately following the approximately 30-minute mental fatigue intervention, during a single study visit lasting up to 2 hours.). The study lists 2 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 29 Sep 2026.