NCT07846618

Brief 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, 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Dec 2027

First Submitted

Initial submission to the registry

September 23, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

mental fatiguemuscle strengthlimb symmetryisokinetic dynamometryelectromyography

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and immediately following the approximately 30-minute mental fatigue intervention, during a single study visit lasting up to 2 hours.

Study Arms (1)

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.

Other: Computer-Based Mental Fatigue Protocol

Interventions

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.

Mental Fatigue Intervention

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Institute for Human and Machine Cognition

Pensacola, Florida, 32502, United States

RECRUITING

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Nicole K Rendos, PhD

    Florida Institute for Human and Machine Cognition

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole K Rendos, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single Group, within-subject, pre-post repeated-measures study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 29, 2026

Study Start

September 23, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 12 months and ending 36 months following publication of the primary findings from this study.
Access Criteria
De-identified data may be shared with scientific and clinical researchers for research purposes, including individual participant data meta-analyses. Requests for data should be directed to Dr. Nicole Rendos at nrendos@ihmc.org and may be submitted up to 36 months following publication of the primary findings from this study. Researchers requesting access will be required to provide an appropriate scientific rationale for the request and sign a data access agreement before receiving the data.

Locations