- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07645404
The Effect of Mental Fatigue on Upper Extremity Functional Performance
12 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
16
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nieka Coryn, MSc
- Número de teléfono: +32 (0)2 629 2222
- Correo electrónico: Nieka.Coryn@vub.be
Copia de seguridad de contactos de estudio
- Nombre: Gürsu Sayar, MSc
- Número de teléfono: +90 534 231 00 72
- Correo electrónico: 6009015@bakircay.edu.tr
Ubicaciones de estudio
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Pleinlaan 2
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Brussels, Pleinlaan 2, Bélgica, 1050
- Vrije Universiteit Brussel
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Contacto:
- Nieka Coryn, MSc
- Número de teléfono: +32 (0)2 629 2222
- Correo electrónico: Nieka.Coryn@vub.be
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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 fatiga mental (FM) es un estado psicobiológico caracterizado por sentimientos de cansancio y/o un deterioro medible en el rendimiento tras una actividad cognitiva prolongada o intensa.
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reactive Upper Quarter Y Balance Test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective Mental Fatigue
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Bart Roelands, Professor, Vrije Universiteit Brussel
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de agosto de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
12 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26014_MF-UEPPT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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