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临床试验/NCT07677345
NCT07677345尚未招募不适用

Lion Tracks EEG Pilot

Penn State University0 个研究点目标入组 20 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Feasibility of Community-Based EEG Assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Shared Exercise Session

Experimental

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.

干预措施: Family-Based Functional Fitness Exercise (Behavioral)

Separate Exercise Session

Active Comparator

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.

干预措施: Independent Functional Fitness Exercise (Behavioral)

结局指标

主要结局

Feasibility of Community-Based EEG Assessment

时间窗: 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.

次要结局

  • Cognitive Performance (Symbol Search Task)(Pre- and post-exercise during each study visit (approximately 60 minutes))
  • Positive and Negative Affect(Immediately before and after each exercise session (approximately 60 minutes))
  • Neurophysiological Activity(Immediately before and after each exercise session (approximately 60 minutes))
  • Parent-Child Connectedness(Immediately following each exercise condition)
  • Exercise Enjoyment(Immediately following each exercise condition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janette Watkins

Assistant Professor

Penn State University

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