- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07754604
Effects of Mental Fatigue Duration on Cortical Activity and Jump Performance (MF-CMJ-EEG)
Duration-Dependent Effects of Mental Fatigue on Cortical Activation Patterns and Lower-Limb Explosive Performance
Panoramica dello studio
Stato
Descrizione dettagliata
"Mental fatigue is a psychobiological state induced by prolonged demanding cognitive activity, characterized by subjective tiredness and measurable decrements in sustained attention and executive control. While mental fatigue has been linked to impairments in endurance, strength, and anaerobic performance, evidence regarding explosive, single-effort tasks such as the countermovement jump (CMJ) remains sparse and inconsistent, and it remains unclear whether the cortical and behavioral consequences of mental fatigue scale with the duration of the inducing cognitive task.
This study used a single-group, repeated-measures crossover design in which the same twelve participants completed a non-fatiguing control condition and three graded mental-fatigue protocols (10, 15, and 30 minutes of continuous Stroop-task performance), with session order counterbalanced across participants and a minimum 72-hour washout between sessions. All sessions were conducted in the same laboratory within a consistent daily time window (10:00 ± 1 hour) to minimize circadian confounds.
Resting-state EEG (spectral power in delta, theta, alpha, and beta bands; theta/alpha and theta/beta ratios; spectral and sample entropy; frontal theta and posterior alpha) and subjective fatigue (0-10 visual analogue scale) were assessed immediately before and after each condition. Countermovement-jump height and its kinetic/kinematic correlates were then measured to evaluate explosive lower-limb power, the study's primary outcome; EEG parameters were treated as secondary, mechanistic outcomes.
Data were analyzed using repeated-measures ANOVA, Holm-Bonferroni-corrected Friedman/Wilcoxon tests where appropriate, and repeated-measures correlation to examine the relationship between post-intervention EEG parameters and CMJ performance. The study tested the hypothesis that increasing Stroop-task duration would produce progressively larger shifts in EEG-derived cortical activation and parallel reductions in CMJ performance, and that these neurophysiological and performance changes would be significantly associated with one another."
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Malatya, Turchia (Türkiye), 44280
- İnönü University, Faculty of Sport Sciences
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Healthy male volunteers aged 18-30 years
- Enrolled in the Faculty of Sport Sciences at İnönü University
- Engaged in structured exercise at least three days per week
- Free of any neurological, psychiatric, cardiovascular, or musculoskeletal disorder
- Normal or corrected-to-normal vision
- Physically capable of completing the experimental protocol safely
Exclusion Criteria:
- Diagnosed neurological, psychiatric, cardiovascular, or musculoskeletal disorder
- Lower-limb injury within the preceding 6 months
- Use of medication known to affect central nervous system function
- Prior diagnosis of a sleep disorder
- Uncorrectable visual impairment or any disturbance of color perception
- Cognitive or sensory limitation likely to interfere with performance of the Stroop task
- Failure to complete a session in full, non-compliance with investigator instructions during testing, inability to produce an EEG recording of analyzable quality for technical reasons, or discontinuation of the experimental procedure for any reason
- Non-compliance with pre-session restrictions (vigorous physical exercise or alcohol consumption within 24 hours before each session; caffeine, energy drinks, or other stimulant substances within 12 hours before each session)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore fittizio: Control
Participants viewed a neutral, cognitively undemanding nature documentary for a duration matched to the mental-fatigue protocols, without performing the Stroop task.
|
Viewing of a neutral, cognitively undemanding nature documentary matched in duration to the mental-fatigue protocols, serving as a non-fatiguing control condition.
|
|
Sperimentale: MF10 (10-min Mental Fatigue)
Participants performed the Stroop color-word task continuously for 10 minutes to induce mental fatigue.
|
Continuous performance of the Stroop color-word interference task for 10 minutes to induce mental fatigue.
|
|
Sperimentale: MF15 (15-min Mental Fatigue)
Participants performed the Stroop color-word task continuously for 15 minutes to induce mental fatigue.
|
Continuous performance of the Stroop color-word interference task for 15 minutes to induce mental fatigue.
|
|
Sperimentale: MF30 (30-min Mental Fatigue)
Participants performed the Stroop color-word task continuously for 30 minutes to induce mental fatigue.
|
Continuous performance of the Stroop color-word interference task for 30 minutes to induce mental fatigue.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Countermovement Jump (CMJ) Height
Lasso di tempo: Immediately after completion of each experimental protocol (control, and 10-, 15-, and 30-minute Stroop-task mental fatigue conditions); sessions were separated by a minimum 72-hour washout period.
|
Countermovement jump (CMJ) height was assessed using the My Jump Lab application (version 5.2; C. Balsalobre-Fernández, Madrid, Spain) via video recorded at 240 frames/s on an iPad Air 11-inch (M3), positioned on a tripod approximately 2 m from the participant.
Take-off and landing frames were identified manually by the same investigator using the application's frame-by-frame function, and jump height was calculated from flight time using the equation h = (g·t²)/8.
Two jump attempts were performed in each experimental session, with 60 seconds of rest between trials, and the better performance was retained for analysis.
|
Immediately after completion of each experimental protocol (control, and 10-, 15-, and 30-minute Stroop-task mental fatigue conditions); sessions were separated by a minimum 72-hour washout period.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Countermovement Jump-Derived Mechanical and Kinematic Parameters
Lasso di tempo: Immediately after completion of each experimental protocol.
|
Countermovement jump (CMJ)-derived mechanical and kinematic parameters were obtained using the My Jump Lab application from the CMJ assessment performed at the end of each experimental protocol.
Average velocity (m/s), take-off velocity (m/s), and impulse (N·s) were provided automatically by the application as derived sub-parameters, computed from jump height and body mass using the biomechanical model incorporated in My Jump Lab.
Flight time (ms) was calculated from the same video recording using the application's frame-by-frame analysis.
These parameters were analyzed as complementary derived measures of CMJ performance.
|
Immediately after completion of each experimental protocol.
|
|
EEG Absolute Band Power (Delta, Theta, Alpha, Beta)
Lasso di tempo: Recorded immediately before and immediately after each experimental protocol (control, and 10-, 15-, and 30-minute Stroop-task mental fatigue conditions); each recording lasted 3 minutes with eyes closed.
|
Resting-state EEG was recorded using a 10-electrode montage (Fp1, Fp2, Fz, FC1, FC2, Cz, Pz, O1, Oz, O2) following the international 10-20 system, via a wireless EEG system (Emotiv EPOC Flex) sampling at 256 Hz.
Following preprocessing (0.5-45 Hz band-pass filtering, ICA-based artifact removal, and amplitude normalization), power spectral density was computed for each channel using Welch's method, and absolute power was calculated within the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13-30 Hz) frequency bands, expressed in normalized (dimensionless) units.
|
Recorded immediately before and immediately after each experimental protocol (control, and 10-, 15-, and 30-minute Stroop-task mental fatigue conditions); each recording lasted 3 minutes with eyes closed.
|
|
EEG Theta/Beta Ratio
Lasso di tempo: Immediately before and immediately after each experimental protocol.
|
The theta-to-beta power ratio was calculated from resting-state EEG recordings (10-electrode montage, international 10-20 system) by dividing theta-band power by beta-band power for each channel.
The outcome was expressed as a unitless ratio.
|
Immediately before and immediately after each experimental protocol.
|
|
EEG Spectral Entropy
Lasso di tempo: Immediately before and immediately after each experimental protocol.
|
Spectral entropy was computed from the resting-state EEG power spectrum of each channel as a measure of signal complexity, used to characterize the transition from an alert to a fatigued cortical state.
|
Immediately before and immediately after each experimental protocol.
|
|
EEG Sample Entropy
Lasso di tempo: Immediately before and immediately after each experimental protocol.
|
Sample entropy was computed from the resting-state EEG time series of each channel as a nonlinear measure of signal irregularity and complexity.
|
Immediately before and immediately after each experimental protocol.
|
|
Frontal Theta Power
Lasso di tempo: Immediately before and immediately after each experimental protocol.
|
Frontal theta power was extracted from frontal electrode sites (Fp1, Fp2, Fz) as a regional marker of cognitive-control demand and effortful attentional monitoring.
|
Immediately before and immediately after each experimental protocol.
|
|
Posterior Alpha Power
Lasso di tempo: Immediately before and immediately after each experimental protocol.
|
Posterior alpha power was extracted from occipital electrode sites (O1, Oz, O2) as a regional marker of cortical inhibition and fatigue-related attentional state.
|
Immediately before and immediately after each experimental protocol.
|
|
Subjective Mental Fatigue (VAS Score)
Lasso di tempo: Immediately before and immediately after each experimental protocol.
|
Subjective mental fatigue was rated using a paper-based 0-10 visual analogue scale, anchored at 0 ("not mentally fatigued at all") and 10 ("the highest possible level of mental fatigue"), in response to the question "How mentally fatigued do you feel right now?" Prior ratings were not visible when a new rating was provided.
|
Immediately before and immediately after each experimental protocol.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- INU-2025-8104-MFCMJ
- 2025/8104 (Altro identificatore: İnönü University Non-Interventional Clinical Research Ethics Committee)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .