- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07677345
Lion Tracks EEG Pilot: Understand Cognitive Responses to CrossFit in Mother-Child Dyads (Lion Tracks)
Lion Tracks EEG Pilot
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Janette Watkins Dr, PhD
- Numero di telefono: 502-321-9683
- Email: jjw7102@psu.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria
- Adult participant is a mother or female primary caregiver aged 18 years or older.
- Child participant is between 4 and 12 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility of Community-Based EEG Assessment
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cognitive Performance (Symbol Search Task)
Lasso di tempo: 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
Lasso di tempo: 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)
|
|
Parent-Child Connectedness
Lasso di tempo: Immediately following each exercise condition
|
Parent-child connectedness will be assessed using the Inclusion of Other in Self (IOS) Scale, a validated single-item pictorial measure of interpersonal closeness.
|
Immediately following each exercise condition
|
|
Exercise Enjoyment
Lasso di tempo: Immediately following each exercise condition
|
Enjoyment of the exercise session will be measured using the Physical Activity Enjoyment Scale (PACES).
|
Immediately following each exercise condition
|
|
Neurophysiological Activity
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Janette Watkins, PhD, The Pennsylvania State University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- STUDY00029189
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Family-Based Functional Fitness Exercise
-
University of KansasUniversity of Kansas Medical CenterCompletatoAdulti più anziani | Disabilità motoriaStati Uniti