- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07809750
Acute Effects of Active Breaks and Physically Active Learning in University Students (PAL UNI)
Acute Effects of Active Breaks and Physically Active Learning on Executive Functions, Interest-Enjoyment, and Academic Performance in University Students
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a multicenter, randomized, counterbalanced crossover study conducted in university students from eight Spanish universities.
Participants will first complete a familiarization session in which study procedures, cognitive assessments, and the participant identification system will be explained and practiced.
Each participant will subsequently complete four experimental sessions, separated by at least one week whenever feasible. Each experimental session will include:
- A 10-minute PRE assessment including Stroop and N-Back tests.
- Approximately 45 minutes of regular academic instruction.
- A 15-minute experimental classroom break.
- Up to 10 additional minutes of regular instruction.
- An immediate POST assessment including Stroop, N-Back, a 10-item academic performance test, perceived exertion, and interest-enjoyment.
The four experimental conditions will be:
A. Sedentary free break without academic content. B. Sedentary academic review using true/false questions. C. Active break without academic content. D. Physically active learning combining the same physical activities used in Condition C with academic true/false questions.
The order of the four conditions will be randomized and counterbalanced across participating groups. Participants will therefore act as their own controls.
A subsample of participants may wear accelerometers to objectively characterize physical activity and sedentary behavior during the experimental sessions.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Carlos Martín-Martínez, PhD
- Telefonnummer: +34914884880
- E-Mail: carlos.martinm@urjc.es
Studienorte
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Navarre
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Pamplona, Navarre, Spanien
- Universidad Pública de Navarra
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Kontakt:
- Óscar Martínez de Quel Pérez, PhD
- Telefonnummer: +34948169479
- E-Mail: oscar.martinezdequel@unavarra.es
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- University students aged 18 years or older.
- Currently enrolled in one of the participating university courses/classes.
- Provision of informed consent.
- Ability to participate safely in light-to-moderate classroom physical activity.
- Ability to complete computerized cognitive assessments.
Exclusion Criteria:
- Injury, illness, or medical condition contraindicating participation in physical activity.
- Acute illness or other condition on the day of testing likely to substantially affect attention or cognitive performance.
- Inability to complete the required computerized cognitive assessments.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Sedentary Free Break
Participants complete a 15-minute sedentary break without structured physical activity or academic review.
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Experimental: Sedentary Academic Review
Participants remain sedentary during a 15-minute academic review activity based on true/false questions related to content presented during the preceding 45 minutes of class.
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A 15-minute sedentary academic review activity using 10 true/false questions based on academic content presented during the first 45 minutes of the session.
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Experimental: Active Break Without Academic Content
Participants complete a standardized 15-minute active break involving moderate physical activities without academic content.
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A standardized 15-minute classroom physical activity break without academic content.
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Experimental: Physically Active Learning
Participants complete a standardized 15-minute physically active learning session combining physical movements with true/false questions related to academic content presented during the preceding 45 minutes.
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A standardized 15-minute intervention combining physical activity with academic true/false questions.
Participants respond to academic questions through predefined physical movements.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Inhibitory Control Assessed by the Stroop Test
Zeitfenster: Immediately before and approximately 10 minutes after the 15-minute experimental condition, during each of the four experimental sessions.
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Inhibitory control will be assessed using the Stroop task.
Outcomes will include response accuracy and reaction time.
Acute change will be calculated by comparing PRE and POST performance within each experimental session.
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Immediately before and approximately 10 minutes after the 15-minute experimental condition, during each of the four experimental sessions.
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Change in Working Memory Assessed by the N-Back Test
Zeitfenster: Immediately before and approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Working memory will be assessed using the N-Back task.
Outcomes will include accuracy, omissions/errors, and reaction time.
Acute change will be calculated from PRE to POST within each experimental session.
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Immediately before and approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Immediate Academic Performance
Zeitfenster: Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Academic performance will be assessed using a 10-item multiple-choice test developed specifically for the academic content taught during each experimental session.
Each question will have three response options and one correct answer.
The outcome will be the number of correct responses, ranging from 0 to 10.
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Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Interest-Enjoyment
Zeitfenster: Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Interest and enjoyment will be assessed using three items from the Interest/Enjoyment subscale of the Intrinsic Motivation Inventory.
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Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Rating of Perceived Exertion
Zeitfenster: Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Perceived exertion during the 15-minute experimental condition will be assessed using a 0-10 Rating of Perceived Exertion scale, where higher scores indicate greater perceived exertion.
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Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Physical Activity During Experimental Sessions
Zeitfenster: Throughout each experimental classroom session, approximately 2 hours.
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In a subsample of participants, triaxial accelerometers will objectively assess sedentary time, light physical activity, moderate-to-vigorous physical activity, and mean activity intensity during the experimental sessions.
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Throughout each experimental classroom session, approximately 2 hours.
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Carlos Martín-Martínez, PhD, Universidad Rey Juan Carlos
- Studienleiter: Óscar Martínez de Quel Pérez, PhD, Universidad Pública de Navarra
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PAL-UNI-2026
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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