- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07645404
The Effect of Mental Fatigue on Upper Extremity Functional Performance
12 juni 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
16
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Nieka Coryn, MSc
- Telefonnummer: +32 (0)2 629 2222
- E-post: Nieka.Coryn@vub.be
Studera Kontakt Backup
- Namn: Gürsu Sayar, MSc
- Telefonnummer: +90 534 231 00 72
- E-post: 6009015@bakircay.edu.tr
Studieorter
-
-
Pleinlaan 2
-
Brussels, Pleinlaan 2, Belgien, 1050
- Vrije Universiteit Brussel
-
Kontakt:
- Nieka Coryn, MSc
- Telefonnummer: +32 (0)2 629 2222
- E-post: Nieka.Coryn@vub.be
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Mental trötthet (MF) är ett psykobiologiskt tillstånd som kännetecknas av trötthetskänslor och/eller ett mätbart prestationsfall efter långvarig eller intensiv kognitiv aktivitet.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reactive Upper Quarter Y Balance Test
Tidsram: Pre-intervention and immediately post-intervention (each experimental and control condition session)
|
Measures visuomotor reaction time, reaching accuracy, and balance errors during a reactive upper quarter Y balance test performed under visual stimuli conditions.
|
Pre-intervention and immediately post-intervention (each experimental and control condition session)
|
|
Closed Kinetic Chain Upper Extremity Stability Test
Tidsram: Pre-intervention and immediately post-intervention (each session)
|
Assesses upper-extremity muscular endurance and stability by counting the number of alternating hand touches performed in a 15-second push-up position task.
|
Pre-intervention and immediately post-intervention (each session)
|
|
Upper Quarter Y Balance Test
Tidsram: Pre-intervention and immediately post-intervention (each session)
|
Evaluates dynamic upper-extremity reach performance and composite score based on normalized reach distances in three directions.
|
Pre-intervention and immediately post-intervention (each session)
|
|
Seated Single-Arm Shot Put Test
Tidsram: Pre-intervention and immediately post-intervention (each session)
|
Measures upper-extremity explosive power based on throwing distance of a 6-lb medicine ball.
|
Pre-intervention and immediately post-intervention (each session)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Subjective Mental Fatigue
Tidsram: Baseline, every 5 minutes during intervention, and post-intervention (each session)
|
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.
|
Baseline, every 5 minutes during intervention, and post-intervention (each session)
|
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Go/No-Go Task
Tidsram: Immediately post-intervention (each session)
|
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)
|
|
Motivation State
Tidsram: Pre- and post-intervention (each session)
|
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.
|
Pre- and post-intervention (each session)
|
|
Perceived Exertion
Tidsram: 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
Tidsram: During intervention (continuous, averaged per block)
|
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.
|
During intervention (continuous, averaged per block)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Bart Roelands, Professor, Vrije Universiteit Brussel
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 augusti 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
9 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26014_MF-UEPPT
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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