NCT03124667

Cognitive Regulation Training and Exercise Trial

Cognitive Regulation Training and Exercise (CORTEX)-II With Middle-Aged Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: University of Illinois at Urbana-Champaign · Academic / Other
• Sex: All
• Age: 35 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Patient Compliance

Interventions

Type	Name	Description
BEHAVIORAL	Games	The game training will emphasize general and exercise-specific dual task processing, self-priming and certainty training.
BEHAVIORAL	Videos	The video training will emphasize health and educational information.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-05-31
• Completion: 2020-10-10
• First posted: 2017-04-24
• Last updated: 2020-12-10

Locations

1 site across 1 country: United States