- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01837004
Cognitive Regulation Training and Exercise (CORTEX)
Cognitive Regulation Training and Exercise (CORTEX) Trial
Visão geral do estudo
Descrição detalhada
Primary Aim 1: To determine the efficacy of pre-intervention cognitive training for improving exercise adherence and engagement. We hypothesize that class participation rates, physical activity counts, and self-reported exercise participation levels will be higher at 4 months for participants in the CORTEX condition relative to the Control condition. We also predict that pre-intervention training will demonstrate high feasibility/acceptability, as indicated by a thorough process evaluation.
Primary Aim 2: To determine if integrated general and exercise-specific cognitive training improves facets of executive function and exercise-related efficacy judgments. We hypothesize that participants in the CORTEX condition will show faster reaction times and greater accuracy for trained and untrained-domain-relevant tasks, including dual task performance, reasoning, and thought-stopping at post-booster testing and 4-month follow-up. Furthermore, we hypothesize that CORTEX participants will show significantly higher levels of exercise efficacy judgments, and exhibit greater automaticity (faster reaction times) in making those judgments, at post-booster testing, 1 month and 4-month follow-up.
Secondary Aim 1: We will use longitudinal mediation analyses to examine mechanisms of change brought about by the cognitive training effects on exercise adherence and engagement. We hypothesize that changes in efficacy and use of self-regulatory strategies will mediate cognitive training effects on exercise adherence over 4-months.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Illinois
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Urbana, Illinois, Estados Unidos, 61801
- University of Illinois
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- men and women
- between 45-64 years old at time of study
- physically inactive for the past 3 months
- have reliable access to internet
- do NOT own or play exergames (Xbox Kinect, Playstation Move, or Nintendo Wii) regularly
- do NOT engage in "brain-training" regularly
- are NOT enrolled in another exercise program or cognitive training study
- willing to be randomized
- able to participant in the full length of the 5-month study with no more than 2 consecutive weeks of vacation
Exclusion Criteria:
- <45 or >64 years of age at time of study
- physically active (i.e., planned 30-min walking or exercise >2 days/wk)
- do not have reliable access to internet
- own and/or play exergames regularly (e.g., 1 day/wk)
- engage in "brain-training" regularly (e.g., Sudoku or computer game-play 1 day/wk)
- enrolled in another exercise program or cognitive training study
- cognitive impairment as defined by TICS score <21
- depression as defined by Geriatric Depression Scale score >5
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: CORTEX
The CORTEX group will attend 10, 2-hour sessions for a period of four weeks prior to the initial exercise program start.
One hour will be devoted to computerized training (stationary dual-task & cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.
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2-hour sessions for a period of four weeks prior to the initial exercise program start.
One hour will be devoted to computerized training (stationary dual-task & cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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exercise adherence
Prazo: 4 months (from exercise intervention baseline to 4-month post-test)
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4 months (from exercise intervention baseline to 4-month post-test)
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exercise program engagement
Prazo: 4 month period (exercise intervention start to end)
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4 month period (exercise intervention start to end)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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automaticity of exercise-related efficacy judgments
Prazo: 5-month period
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-reaction times and interference associated with a novel self-efficacy judgment task; collected at baseline, m1, and m5
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5-month period
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exercise-related self-efficacy
Prazo: 5-month period
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-self-reported confidence in one's ability to adhere to different aspects of the exercise program; collected at baseline, m1, m2, and m5
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5-month period
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executive functioning
Prazo: 5-month period
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-trained and untrained domains of executive functioning (e.g., dual-task ability, inhibitory control, reasoning) and memory assessed via computer-based and pencil-paper tasks; collected at baseline, 1m, and 5m
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5-month period
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sean P Mullen, Ph.D., University of Illinois at Urbana-Champaign
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 1R21HL11341001A1
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