- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07645404
The Effect of Mental Fatigue on Upper Extremity Functional Performance
12. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
16
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Nieka Coryn, MSc
- Telefonnummer: +32 (0)2 629 2222
- E-post: Nieka.Coryn@vub.be
Studer Kontakt Backup
- Navn: Gürsu Sayar, MSc
- Telefonnummer: +90 534 231 00 72
- E-post: 6009015@bakircay.edu.tr
Studiesteder
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Pleinlaan 2
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Brussels, Pleinlaan 2, Belgia, 1050
- Vrije Universiteit Brussel
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Ta kontakt med:
- Nieka Coryn, MSc
- Telefonnummer: +32 (0)2 629 2222
- E-post: Nieka.Coryn@vub.be
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Mental utmattelse (MF) er en psykobiologisk tilstand karakterisert av følelser av tretthet og/eller en målbart nedgang i prestasjon etter langvarig eller intens kognitiv aktivitet.
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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Reactive Upper Quarter Y Balance Test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Subjective Mental Fatigue
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Bart Roelands, Professor, Vrije Universiteit Brussel
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. august 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
9. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26014_MF-UEPPT
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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