- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07749937
Sports-Based Cognitive Game Program and Attention in Athletes
The Effect of a Sports-Based Cognitive Game Development Program on Attention Level and Prefrontal EEG Theta/Beta Ratio
This study looked at whether a 12-week sports-based cognitive game program could improve attention and change brain activity in athletes. Ninety-five active athletes from Düzce University were randomly placed into two groups. One group (45 people) took part in a cognitive game program twice a week for 12 weeks, in addition to their regular sports training. Each session lasted 45 minutes and included games designed to build attention, reaction speed, decision-making, and multitasking skills. The other group (50 people) continued their usual sports training without any additional program.
Before and after the 12 weeks, all participants completed a paper-and-pencil attention test (the d2 Attention Test) and had a short, painless brain-wave recording (EEG) taken from the forehead area while sitting quietly with their eyes closed. The researchers compared how much each group's attention scores and brain-wave patterns changed over the 12 weeks.
The results showed that the group who took part in the cognitive game program improved significantly more in attention performance than the group who did not, and also showed a favorable change in their brain-wave pattern (a lower theta/beta ratio, which is linked to better attention control). The group that continued regular training without the program showed little change in either measure.
These findings suggest that adding structured, game-based cognitive training to regular sports training may offer additional benefits for attention and brain function beyond physical training alone.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study used a pre-test-post-test, randomized controlled experimental design to examine the effects of a 12-week sports-based cognitive game development program on selective attention performance and prefrontal EEG theta/beta ratio (TBR) in active university athletes.
Participants were randomly assigned to an experimental group (n = 45) or a control group (n = 50) using a computer-assisted random number table. Baseline equivalence between groups was confirmed for both outcome measures prior to the intervention (d2 TNE: t(93) = -0.514, p = .608; Fz theta/beta: t(93) = 1.128, p = .262).
The experimental group participated in a structured, five-stage sports-based cognitive game development program, delivered twice weekly for 12 weeks (24 sessions total, 45 minutes per session). The program followed a gradual cognitive load principle across five stages: (1) adaptation and basic cognitive infrastructure, (2) attention and reaction development, (3) decision-making and strategy, (4) concentration and multitasking performance, and (5) reinforcement and transfer to sport. Each session consisted of five fixed components: greeting and orientation (3 min), attention warm-up exercises (5 min), cognitive reaction games (15 min), strategy and decision-making games (15 min), and evaluation/closing (7 min). Sessions were delivered by a single PhD-level sport sciences researcher, and fidelity was monitored using structured session control forms.
The control group continued their regular sports training without any additional intervention during the 12-week period.
Outcome measures were collected at baseline and following the 12-week period:
- Selective attention performance was assessed using the d2 Attention Test, with the Total Net Error (TNE) score as the primary behavioral outcome (TNE = TN - E2).
- Prefrontal EEG theta (4-8 Hz) to beta (13-21 Hz) power ratio was recorded from the Fz electrode (International 10-20 system, linked-earlobe reference A1-A2) using a Nexus 10 Mk II neurofeedback device and BioTrace+ software, during a 10-minute eyes-closed resting condition (first and last 30 seconds discarded; minimum 8 minutes of artifact-free data required per participant).
The d2 Attention Test and EEG recording were conducted in separate sessions on the same day, in a fixed order (d2 test first, then EEG), separated by a minimum 30-minute rest interval, to control for order and fatigue effects.
Data were analyzed using 2 (Group: Experimental, Control) x 2 (Time: Pre-test, Post-test) mixed-design ANOVA, with Bonferroni-corrected post hoc comparisons (adjusted alpha = .0125) and Welch t-tests where variance homogeneity was violated. Gender was examined as a covariate using ANCOVA, given its known association with EEG frequency characteristics; gender did not significantly affect either outcome after controlling for pre-test scores.
Note: As data collection for this study was already complete at the time of registration, this is a retrospective trial registration.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Düzce, Turquia (Türkiye), 81620
- Duzce University, Faculty of Sport Sciences
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Actively engaged in sports/regular athletic training
- No neurological or psychiatric diagnosis in the past six months
- Continuing a regular exercise program throughout the study period
- Full participation in all intervention sessions (for experimental group) or willingness to continue regular sports training (for control group)
- Aged 18-25 years
- Voluntary participation with written informed consent
Exclusion Criteria:
- Neurological or psychiatric diagnosis within the past six months
- Inability to attend the required number of sessions
- Withdrawal of informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Experimental Group
Participants received a 12-week sports-based cognitive game development program (24 sessions, twice weekly, 45 min/session) in addition to regular sports training.
|
A structured, five-stage sports-based cognitive game development program delivered twice weekly for 12 weeks (24 sessions total, 45 minutes per session), in addition to participants' regular sports training.
The program followed a gradual cognitive load principle across five stages: (1) adaptation and basic cognitive infrastructure, (2) attention and reaction development, (3) decision-making and strategy, (4) concentration and multitasking performance, and (5) reinforcement and transfer to sport.
Each session included five components: greeting and orientation (3 min), attention warm-up exercises (5 min), cognitive reaction games (15 min), strategy and decision-making games (15 min), and evaluation/closing (7 min).
Sessions were delivered by a single PhD-level sport sciences researcher.
|
|
Sem intervenção: Control Group
Participants continued their regular sports training without any additional intervention during the 12-week period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
d2 Attention Test Total Net Error (TNE) Score
Prazo: Baseline (pre-test) and after 12 weeks (post-test)
|
Selective attention performance measured by the Total Net Error (TNE) score of the d2 Attention Test, calculated as TNE = TN (total correctly marked targets) - E2 (commission errors).
Higher scores indicate better selective attention performance.
|
Baseline (pre-test) and after 12 weeks (post-test)
|
|
Fz EEG Theta/Beta Ratio
Prazo: Baseline (pre-test) and after 12 weeks (post-test)
|
Prefrontal EEG theta (4-8 Hz) to beta (13-21 Hz) power ratio, recorded from the Fz electrode using the Nexus 10 Mk II device during a 10-minute eyes-closed resting condition.
Lower ratios indicate better attention regulation and prefrontal inhibitory capacity.
|
Baseline (pre-test) and after 12 weeks (post-test)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yeşer Eroğlu Eskicioğlu, PhD, Düzce University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- E-78187535-050.04-426788
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .