- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07645404
The Effect of Mental Fatigue on Upper Extremity Functional Performance
12 juin 2026 mis à jour par: Gürsu Sayar, Izmir Bakircay University
Mental fatigue (MF) is known to impair cognitive performance and may negatively affect physical performance.
While its effects on lower-extremity functional performance have been investigated, little is known about the influence of MF on upper-extremity physical performance tests commonly used in sports and rehabilitation settings.
This randomized crossover study will investigate the effects of experimentally induced mental fatigue on upper-extremity physical performance in 16 healthy physically active adults.
Participants will complete both a mental fatigue condition, involving a prolonged Stroop task, and a control condition consisting of watching an emotionally neutral documentary.
Before and after each condition, participants will perform the Upper Quarter Y Balance Test, Reactive Upper Quarter Y Balance Test, Closed Kinetic Chain Upper Extremity Stability Test, and Seated Single-Arm Shot Put Test.
Subjective mental fatigue, cognitive performance, motivation, and perceived exertion will also be assessed.
The findings will improve understanding of whether mental fatigue influences upper-extremity physical performance test outcomes and may assist clinicians and researchers in interpreting these assessments in sports medicine and rehabilitation contexts.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
16
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Nieka Coryn, MSc
- Numéro de téléphone: +32 (0)2 629 2222
- E-mail: Nieka.Coryn@vub.be
Sauvegarde des contacts de l'étude
- Nom: Gürsu Sayar, MSc
- Numéro de téléphone: +90 534 231 00 72
- E-mail: 6009015@bakircay.edu.tr
Lieux d'étude
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Pleinlaan 2
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Brussels, Pleinlaan 2, Belgique, 1050
- Vrije Universiteit Brussel
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Contact:
- Nieka Coryn, MSc
- Numéro de téléphone: +32 (0)2 629 2222
- E-mail: Nieka.Coryn@vub.be
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Age between 18 and 35 years
- Healthy (no neurological, cardiovascular or musculoskeletal disorders of any kind)
- Male or female
- No prior knowledge of the concept of mental fatigue
- Not currently taking medications that affect cognition or neuromuscular performance
- According to the International Physical Activity Questionnaire, being physically active at a minimum level of 1500 MET-min/week
Exclusion Criteria:
- Previous major upper limb injury (last 6 months)
- Involvement in another concurrent physical or cognitive intervention study
- Use of caffeine and heavy efforts 24 hours prior each trial
- Suffering from colour vision deficiencies
- Not eating a standardized meal, the morning of each trial and the evening before each trial
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Mental Fatigue Condition
Participants in this arm completed a mental fatigue induction protocol involving a prolonged and cognitively demanding Stroop task designed to induce sustained inhibitory control and attentional effort.
The task was performed for an extended duration to elicit subjective mental fatigue.
Pre- and post-condition assessments of upper-extremity physical performance, cognitive performance, motivation, perceived exertion, and subjective mental fatigue were conducted.
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La fatigue mentale (MF) est un état psychobiologique caractérisé par des sensations de fatigue et/ou une diminution mesurable des performances suite à une activité cognitive prolongée ou intense.
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Aucune intervention: Control condition
Participants in this arm watched a neutral, emotionally non-arousing documentary for an equivalent duration as the mental fatigue condition.
This activity was designed to minimize cognitive load and avoid inducing mental fatigue.
Pre- and post-condition assessments of upper-extremity physical performance, cognitive performance, motivation, perceived exertion, and subjective mental fatigue were conducted.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Reactive Upper Quarter Y Balance Test
Délai: Pre-intervention and immediately post-intervention (each experimental and control condition session)
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Measures visuomotor reaction time, reaching accuracy, and balance errors during a reactive upper quarter Y balance test performed under visual stimuli conditions.
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Pre-intervention and immediately post-intervention (each experimental and control condition session)
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Closed Kinetic Chain Upper Extremity Stability Test
Délai: Pre-intervention and immediately post-intervention (each session)
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Assesses upper-extremity muscular endurance and stability by counting the number of alternating hand touches performed in a 15-second push-up position task.
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Pre-intervention and immediately post-intervention (each session)
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Upper Quarter Y Balance Test
Délai: Pre-intervention and immediately post-intervention (each session)
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Evaluates dynamic upper-extremity reach performance and composite score based on normalized reach distances in three directions.
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Pre-intervention and immediately post-intervention (each session)
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Seated Single-Arm Shot Put Test
Délai: Pre-intervention and immediately post-intervention (each session)
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Measures upper-extremity explosive power based on throwing distance of a 6-lb medicine ball.
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Pre-intervention and immediately post-intervention (each session)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subjective Mental Fatigue
Délai: Baseline, every 5 minutes during intervention, and post-intervention (each session)
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Subjective Mental Fatigue measured using the Mental Visual Analog Scale (M-VAS).
The scale ranges from 0 to 100, where 0 indicates no mental fatigue and 100 indicates the highest level of mental fatigue imaginable.
Higher scores indicate worse mental fatigue.
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Baseline, every 5 minutes during intervention, and post-intervention (each session)
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Go/No-Go Task
Délai: Immediately post-intervention (each session)
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Assesses executive function using a computerized Go/No-Go task.
Outcomes include reaction time (milliseconds) and response accuracy (percentage of correct responses, ranging from 0% to 100%).
Higher accuracy indicates better executive function performance, while shorter reaction times indicate better performance.
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Immediately post-intervention (each session)
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Motivation State
Délai: Pre- and post-intervention (each session)
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Assesses task-related motivation using the Assessment of Motivational States in Performance Environments questionnaire.
The questionnaire includes two 7-item subscales: Interest Motivation and Success Motivation.
Higher scores indicate greater task engagement, interest in the task, and motivation to perform successfully.
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Pre- and post-intervention (each session)
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Perceived Exertion
Délai: Immediately after physical performance testing (each session)
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Assesses perceived exertion using the Borg Rating of Perceived Exertion Scale.
Scores range from 6 to 20, with higher scores indicating greater perceived exertion.
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Immediately after physical performance testing (each session)
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Stroop Task Performance
Délai: During intervention (continuous, averaged per block)
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Assesses cognitive performance using a computerized Stroop task.
Outcomes include reaction time (milliseconds) and response accuracy (percentage of correct responses, ranging from 0% to 100%).
Higher accuracy and shorter reaction times indicate better cognitive performance.
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During intervention (continuous, averaged per block)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Bart Roelands, Professor, Vrije Universiteit Brussel
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 août 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26014_MF-UEPPT
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data (IPD) will be shared upon reasonable request.
This includes baseline characteristics, intervention allocation, and all primary and secondary outcome measures (upper-extremity physical performance test results, cognitive performance data, subjective mental fatigue scores, motivation scores, perceived exertion ratings, and Stroop task performance data).
All data will be fully anonymized to protect participant confidentiality.
Additional study-related materials such as the study protocol and statistical analysis plan may also be made available.
Data will be shared for non-commercial research purposes after publication of the main study results.
Délai de partage IPD
IPD and supporting documents will become available beginning 6 months after publication of the primary study results and will remain accessible for a period of 5 years.
Critères d'accès au partage IPD
De-identified individual participant data (IPD) and supporting study documents will be made available to qualified researchers upon reasonable request for non-commercial use.
Requests must include a methodologically sound research proposal and will be reviewed and approved by the principal investigator or study sponsor.
Data will be shared under a data-sharing agreement to ensure compliance with ethical and data protection regulations.
Access will be provided via secure data transfer platforms or institutional repositories.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .