- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07677345
Lion Tracks EEG Pilot: Understand Cognitive Responses to CrossFit in Mother-Child Dyads (Lion Tracks)
Lion Tracks EEG Pilot
Обзор исследования
Статус
Условия
Подробное описание
Physical activity is associated with improvements in cognitive function, emotional well-being, and overall health across the lifespan. Emerging evidence suggests that social and relational contexts may influence the benefits derived from physical activity, yet little research has examined how exercising together versus separately affects parent-child dyads. Understanding these effects may inform the development of family-centered physical activity interventions that promote both physical and psychological health.
The purpose of this pilot study is to evaluate the feasibility of conducting community-based neurocognitive research within fitness settings and to explore acute changes in cognitive, emotional, and neurophysiological outcomes following exercise. Mother-child dyads will participate in two exercise conditions: a shared exercise session in which mothers and children participate together, and a separate exercise session in which mothers and children participate in age-appropriate classes independently. A within-subjects design will allow each dyad to experience both conditions.
Cognitive performance, mood, and brain activity will be assessed before and after exercise using brief computerized assessments and portable electroencephalography (EEG). Feasibility outcomes will include recruitment, retention, adherence, participant acceptability, and data quality. Exploratory analyses will examine whether exercise context (shared versus separate participation) is associated with differences in cognitive, emotional, and neurophysiological responses.
Findings from this study will provide preliminary data to support future investigations of family-based physical activity interventions and their potential effects on brain health, emotional well-being, and parent-child relationships.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Janette Watkins Dr, PhD
- Номер телефона: 502-321-9683
- Электронная почта: jjw7102@psu.edu
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria
- Adult participant is a mother or female primary caregiver aged 18 years or older.
- Child participant is at least 3 years of age.
- Mother and child are willing to participate together as a dyad.
- Mother and child are able to understand and speak English.
- Mother and child are willing to attend two study visits at a participating community fitness facility.
- Mother and child are able to safely participate in moderate-to-vigorous physical activity as determined by health screening procedures.
- Mother is willing to provide informed consent and child is willing to provide assent when appropriate.
Exclusion Criteria *Mother*
- Pregnancy at the time of participation.
- Any cardiovascular, metabolic, respiratory, neurological, musculoskeletal, or other medical condition that would make exercise unsafe.
- Current injury or physical limitation preventing participation in exercise.
- History of seizure disorder or other condition that may interfere with EEG assessment.
- Inability to complete study procedures or wear EEG equipment. *Child*
- Medical condition, injury, or physical limitation that would make participation in exercise unsafe.
- Neurological condition or developmental disorder that would prevent completion of study procedures, as determined by the parent and study team.
- History of seizure disorder or other condition that may interfere with EEG assessment.
- Inability to tolerate wearing the EEG headset or complete study procedures. *Dyad*
- Either the mother or child is unable or unwilling to complete both study visits.
- Either participant has a contraindication to exercise identified during screening.
- Either participant has a condition that, in the opinion of the investigators, would make participation unsafe or compromise data quality.
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 |
|---|---|
|
Экспериментальный: Shared Exercise Session
Participants assigned to this condition will complete a mother-child exercise session together at a participating community fitness facility/CrossFit affiliate.
The session will consist of approximately 60 minutes of instructor-led functional fitness activities, including a warm-up, skill or strength-based exercises, conditioning activities, and cool-down.
Mothers and children will participate alongside one another throughout the session.
Cognitive performance, mood, and brain activity will be assessed immediately before and after the exercise session using brief computerized tasks, questionnaires, and portable electroencephalography (EEG).
Participants will complete this condition once during the study.
|
A supervised mother-child functional fitness exercise session conducted in a community fitness setting.
Mothers and children participate together in approximately 60 minutes of age-appropriate exercise activities.
|
|
Активный компаратор: Separate Exercise Session
Participants assigned to this condition will complete exercise sessions in separate age-appropriate classes at a participating community fitness facility/CrossFit affiliate.
Mothers will participate in an adult functional fitness class, while children will participate in a youth fitness class occurring concurrently.
Sessions will last approximately 60 minutes and will include instructor-led warm-up, skill or strength-based exercises, conditioning activities, and cool-down.
Mothers and children will exercise independently and will not participate in the same class activities during this condition.
Cognitive performance, mood, and brain activity will be assessed immediately before and after the exercise session using brief computerized tasks, questionnaires, and portable electroencephalography (EEG).
Participants will complete this condition once during the study.
|
Participants will complete an approximately 60-minute functional fitness exercise session in a community fitness setting.
Mothers will participate in an instructor-led adult fitness class while children simultaneously participate in an age-appropriate youth fitness class.
Sessions may include warm-up activities, movement skill instruction, strength or conditioning exercises, games, and cool-down activities.
Mothers and children will exercise separately throughout the session and will not participate in the same class activities.
This condition is designed to examine the effects of exercise performed independently compared with exercise performed together as a mother-child dyad.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasibility of Community-Based EEG Assessment
Временное ограничение: Throughout study completion (approximately 2 study visits over 1-2 weeks)
|
Feasibility will be evaluated through recruitment, retention, session completion, questionnaire completion, cognitive task completion, and acquisition of usable EEG recordings using the EMOTIV EPOC X portable electroencephalography system.
Data quality will be assessed by the proportion of participants providing analyzable EEG and cognitive data.
|
Throughout study completion (approximately 2 study visits over 1-2 weeks)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cognitive Performance (Symbol Search Task)
Временное ограничение: Pre- and post-exercise during each study visit (approximately 60 minutes)
|
Processing speed and visual attention will be assessed using the M2C2 Symbol Search task.
Outcomes include response accuracy and reaction time.
|
Pre- and post-exercise during each study visit (approximately 60 minutes)
|
|
Positive and Negative Affect
Временное ограничение: Immediately before and after each exercise session (approximately 60 minutes)
|
Mood will be assessed using the 10-item International Positive and Negative Affect Schedule Short Form (I-PANAS-SF).
Scores for positive affect and negative affect will be calculated according to published scoring procedures.
|
Immediately before and after each exercise session (approximately 60 minutes)
|
|
Neurophysiological Activity
Временное ограничение: Immediately before and after each exercise session (approximately 60 minutes)
|
Brain activity will be assessed using the EMOTIV EPOC X wireless electroencephalography (EEG) system.
Outcomes may include resting-state spectral power within delta, theta, alpha, beta, and gamma frequency bands, as well as frontal alpha asymmetry and other exploratory EEG-derived markers of cognitive engagement and neural activation.
|
Immediately before and after each exercise session (approximately 60 minutes)
|
|
Parent-Child Connectedness
Временное ограничение: Immediately following each exercise condition
|
Parent-child connectedness will be assessed using the Inclusion of Other in the Self (IOS) Scale, a validated single-item pictorial measure of perceived interpersonal closeness.
Mothers select one of seven increasingly overlapping pairs of circles representing the relationship between themselves and their child.
Scores range from 1 (least connected) to 7 (most connected), with higher scores indicating greater perceived parent-child connectedness.
|
Immediately following each exercise condition
|
|
Exercise Enjoyment
Временное ограничение: Immediately following each exercise condition
|
Enjoyment of the exercise session will be assessed using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment experienced during physical activity.
Scores range from 1 to 5, with the overall score calculated as the mean of all items.
Higher scores indicate greater enjoyment of the exercise session.
|
Immediately following each exercise condition
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Janette Watkins, PhD, The Pennsylvania State University
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
Другие идентификационные номера исследования
- STUDY00029189
Планирование данных отдельных участников (IPD)
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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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