Cognitive Regulation Training and Exercise (CORTEX) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- exercise program engagement
研究概览
简要总结
The purpose of this study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, general and exercise-specific cognitive training program plus a 4-month exercise program, to an attention-control condition involving health and wellness informational lectures plus videos. The proposed exercise program will involve both aerobic and resistive exercises. The investigators hypothesize that pre-intervention cognitive training will enhance self-regulation and self-efficacy and in turn, increase exercise adherence. The investigators also expect more positive improvements in cognitive and psychosocial function among participants in the CORTEX condition as compared to the Control condition immediately following the cognitive booster training, and across time.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •<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
结局指标
主要结局
exercise program engagement
时间窗: 4 month period (exercise intervention start to end)
* self-reported physical activity * activity counts assessed via accelerometer * weekly exercise logs * website usage \& percentage of online educational modules completed
exercise adherence
时间窗: 4 months (from exercise intervention baseline to 4-month post-test)
* number of weekly classes attended (out of 16 total) * frequency of electronically-recorded visits to the fitness facility
次要结局
- exercise-related self-efficacy(5-month period)
- automaticity of exercise-related efficacy judgments(5-month period)
- executive functioning(5-month period)