- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Carlos Martín-Martínez, PhD
- Номер телефона: +34914884880
- Электронная почта: carlos.martinm@urjc.es
Места учебы
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Navarre
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Pamplona, Navarre, Испания
- Universidad Pública de Navarra
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Контакт:
- Óscar Martínez de Quel Pérez, PhD
- Номер телефона: +34948169479
- Электронная почта: oscar.martinezdequel@unavarra.es
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Без вмешательства: Sedentary Free Break
Participants complete a 15-minute sedentary break without structured physical activity or academic review.
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Экспериментальный: 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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Экспериментальный: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Inhibitory Control Assessed by the Stroop Test
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Interest-Enjoyment
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physical Activity During Experimental Sessions
Временное ограничение: 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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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Carlos Martín-Martínez, PhD, Universidad Rey Juan Carlos
- Директор по исследованиям: Óscar Martínez de Quel Pérez, PhD, Universidad Pública de Navarra
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PAL-UNI-2026
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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