- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Carlos Martín-Martínez, PhD
- Número de telefone: +34914884880
- E-mail: carlos.martinm@urjc.es
Locais de estudo
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Navarre
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Pamplona, Navarre, Espanha
- Universidad Pública de Navarra
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Contato:
- Óscar Martínez de Quel Pérez, PhD
- Número de telefone: +34948169479
- E-mail: oscar.martinezdequel@unavarra.es
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Inhibitory Control Assessed by the Stroop Test
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Interest-Enjoyment
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Physical Activity During Experimental Sessions
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carlos Martín-Martínez, PhD, Universidad Rey Juan Carlos
- Diretor de estudo: Óscar Martínez de Quel Pérez, PhD, Universidad Pública de Navarra
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PAL-UNI-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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