- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Carlos Martín-Martínez, PhD
- Telefoonnummer: +34914884880
- E-mail: carlos.martinm@urjc.es
Studie Locaties
-
-
Navarre
-
Pamplona, Navarre, Spanje
- Universidad Pública de Navarra
-
Contact:
- Óscar Martínez de Quel Pérez, PhD
- Telefoonnummer: +34948169479
- E-mail: oscar.martinezdequel@unavarra.es
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Sedentary Free Break
Participants complete a 15-minute sedentary break without structured physical activity or academic review.
|
|
|
Experimenteel: 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.
|
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.
|
|
Experimenteel: Active Break Without Academic Content
Participants complete a standardized 15-minute active break involving moderate physical activities without academic content.
|
A standardized 15-minute classroom physical activity break without academic content.
|
|
Experimenteel: 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.
|
A standardized 15-minute intervention combining physical activity with academic true/false questions.
Participants respond to academic questions through predefined physical movements.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Inhibitory Control Assessed by the Stroop Test
Tijdsspanne: Immediately before and approximately 10 minutes after the 15-minute experimental condition, during each of the four experimental sessions.
|
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.
|
Immediately before and approximately 10 minutes after the 15-minute experimental condition, during each of the four experimental sessions.
|
|
Change in Working Memory Assessed by the N-Back Test
Tijdsspanne: Immediately before and approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
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.
|
Immediately before and approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
|
Immediate Academic Performance
Tijdsspanne: Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
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.
|
Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Interest-Enjoyment
Tijdsspanne: Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
Interest and enjoyment will be assessed using three items from the Interest/Enjoyment subscale of the Intrinsic Motivation Inventory.
|
Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
|
Rating of Perceived Exertion
Tijdsspanne: Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
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.
|
Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Physical Activity During Experimental Sessions
Tijdsspanne: Throughout each experimental classroom session, approximately 2 hours.
|
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.
|
Throughout each experimental classroom session, approximately 2 hours.
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Carlos Martín-Martínez, PhD, Universidad Rey Juan Carlos
- Studie directeur: Óscar Martínez de Quel Pérez, PhD, Universidad Pública de Navarra
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PAL-UNI-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .