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Набор скоро начнётся NCT07677345

Lion Tracks EEG Pilot: Understand Cognitive Responses to CrossFit in Mother-Child Dyads

Без фазы С лечением Cognition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Family-Based Functional Fitness Exercise, Independent Functional Fitness Exercise.
Кому может быть актуально
Состояния в реестре: Cognition. Базовые параметры: от 3 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Lion Tracks EEG Pilot

Обзор

The purpose of this study is to examine how participating in exercise together versus separately influences brain function, cognitive performance, mood, and parent-child connection in mother-child dyads. Mothers and their children will complete two fitness class visits at a participating community fitness facility/CrossFit affiliate. During one visit, mothers and children will exercise in separate age-appropriate classes, and during the other visit they will exercise together in a shared class. Before and after each exercise session, participants will complete brief assessments of cognition, mood, and brain activity using a portable electroencephalography (EEG) device. Findings from this pilot study will help determine the feasibility of conducting community-based neuroscience research and may inform future family-centered physical activity programs designed to support brain, emotional, and social health.

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.

Вмешательства

  • Поведенческое Family-Based Functional Fitness Exercise
    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.
  • Поведенческое Independent Functional Fitness Exercise
    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 partici

Первичные конечные точки

  • Feasibility of Community-Based EEG Assessment [Срок оценки: Throughout study completion (approximately 2 study visits over 1-2 weeks)]
Вторичные конечные точки (5)
  • Cognitive Performance (Symbol Search Task) [Срок оценки: Pre- and post-exercise during each study visit (approximately 60 minutes)]
  • Positive and Negative Affect [Срок оценки: Immediately before and after each exercise session (approximately 60 minutes)]
  • Parent-Child Connectedness [Срок оценки: Immediately following each exercise condition]
  • Exercise Enjoyment [Срок оценки: Immediately following each exercise condition]
  • Neurophysiological Activity [Срок оценки: Immediately before and after each exercise session (approximately 60 minutes)]

Критерии участия

Критерии включения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07677345 · STUDY00029189

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗