Cognitive Regulation Training and Exercise (CORTEX)-II With Middle-Aged Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Exercise self-regulation
研究概览
简要总结
The purpose of this double-blinded, randomized controlled study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, center- and home-delivered- general and exercise-specific-active and traditional computerized cognitive training (CT) program to an attention-control condition involving health and wellness informational videos. More specifically, the cognitive training group will emphasize dual-task abilities, working memory, and visual-spatial processing, as well as self-as-exerciser priming and self-certainty training. It is hypothesized that early intervention cognitive training will enhance use of self-regulatory strategies and self-efficacy and in turn, increase exercise adherence to and engagement in a 12-month aerobic and resistive exercise program at a local fitness facility. More positive improvements in cognitive and psychosocial functioning among participants in the CORTEX condition (relative to the Video Attention-Control condition, i.e., health educational videos), are also expected immediately following the cognitive training, and across time. Expectancies and knowledge of study purpose (blinding integrity) will also be measured and used to statistically adjust for any training differences.
详细描述
Primary Aim: To test the effectiveness of a 1-month CT (randomized group condition) on exercise self-regulation, a latent factor representing 12-Month exercise adherence & program engagement (i.e., supervised & unsupervised class participation rates, electronically-recorded visitations, Fitbit-derived step counts, & self-reported leisure-time exercise), the investigators will use a structural equation model with robust maximum likelihood estimation. Exercise self-regulation will be regressed on group and known covariates (age, gender, education level, training compliance [percentage of completed sessions], and injury/illness). It is hypothesized that the CORTEX condition will show increased exercise self-regulation (and lower dropout, a categorical outcome variable, tested in a parallel model) compared to the Video Attention-Control condition.
Secondary Aims: A generalized latent variable framework will be used to test the researchers' theorized model and exploratory questions to determine if the CT contributes to greater cognitive change and enhanced perceptions of memory strategy use, self-efficacy, and self-reported physical activity-specific planning and self-regulatory strategy-use; and in turn, greater exercise self-regulation/ lower dropout. To evaluate these questions, first and second-order latent change scores will be derived representing general & exercise-specific cognitive functioning (reaction times and accuracy within training domains), self-efficacy and self-reported self-regulatory strategies, and will be added to the latent exercise self-regulation measurement model (and adjusted with known covariates, i.e., group, age, gender, education, compliance, injury/illness). Positive indirect effects of CT condition on 12-month exercise self-regulation are expected through the change in theoretical constructs-dual task and memory performance, implicit attitudes, memory strategy-use, self-efficacy, exercise planning and physical activity-specific self-regulatory strategy-use. Researchers also predict that the CT program will demonstrate high feasibility/acceptability, as indicated by a thorough process evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Low active for the past 3 months
- •35 to 64 years old
- •Do NOT regularly play exergames (e.g., XBox Kinect, Playstation Move, Nintendo Wii)
- •Do NOT engage in "brain training" regularly (less than once per week)
- •Are NOT enrolled in another exercise program or cognitive training study
- •Able and willing to comply with the study length, testing, training and exercise program requirements
- •Lives within 20 miles of the fitness facility and UIUC research facility
- •Has reliable at-home Wi-Fi internet access and an available port for plugging in XBox console
- •Vision is at least 20/40 with glasses or contacts with no color blindness
- •Do NOT have depression (as defined by a score of 2 or less on the abbreviated Geriatric Depression Scale [GDS-5])
- •Do NOT have cognitive impairment (as defined by a score of 21 or higher on the Telephone Interview Cognitive Survey [TICS])
排除标准
- •Previously involved in the first CORTEX trial
- •Currently involved in regular weekly cognitive training or another physical activity program or study (e.g., yoga, meditation)
- •Too active (as defined by regularly exercise 2 or more days per week for 30+ minutes over the past 3 months)
- •Incapable of performing moderately intensive aerobic exercise (must be able to complete basic movements, i.e., walking, jogging, jumping, side-stepping, throwing, kicking, punching, grabbing) without exacerbating a pre-existing condition caused by overuse, surgery, or other chronic condition
- •Unable or unwilling to comply to lab and home-based training and physical activity prescription
- •Unable to commit to full length of program
- •Unwilling to be randomized to one of two groups
- •Home residence exceeds 20 mile radius from fitness facility or unable to commute to and from fitness facility and UIUC campus
- •Do not have reliable at-home Wi-Fi internet access or a required port for plugging in Xbox
- •Uncorrectable vision (i.e., less than 20/40 with glasses or contacts with color blindness)
- •Depression as defined by GDS >2
- •Cognitive impairment as defined by TICS < 21
结局指标
主要结局
Exercise self-regulation
时间窗: 12 months
Exercise self-regulation will be modeled within a latent variable framework. The change factor will be reflected by accumulated supervised and unsupervised class participation rates, total electronically-recorded visitations, averaged monthly Fitbit-derived step counts, and self-reported leisure-time exercise (via Godin Leisure-Time Questionnaire). Measures will be standardized as z-scores. The latent factor model will be adjusted for known covariates (age, gender, education level, training compliance \[percentage of completed sessions\] and injury/illness) when primary hypothesis of group effects is tested. There is always the possibility that attempts to analyze latent constructs will not converge as planned. In such a case, researchers will attempt to assess change across each behavioral outcome individually with a robust linear regression method, adjusting for multiple comparisons.
次要结局
- Exercise self-efficacy (change)(1 month)
- Exercise planning (change)(1 month)
- Memory strategy-use (change)(1 month)
- Dual task functioning (change)(1 month)
- Physical activity self-regulatory strategy-use (change)(1 month)
- Memory functioning (change)(1 month)
研究者
Sean Mullen
Assistant Professor
University of Illinois at Urbana-Champaign