Cognitive Regulation Training and Exercise Trial
Condition: Patient Compliance
Study type: Interventional

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.
    

Intervention name(s): Games; Videos
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The game training will emphasize general and exercise-specific dual task processing, self-priming and certainty training.; The video training will emphasize health and educational information.
Other intervention name(s): Gaming Condition; Video Condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adherence; cognition; exercise; aging; brain training; cognitive training; executive function