Clinical trial NCT03124667: Cognitive Regulation Training and Exercise Trial
Official title: Cognitive Regulation Training and Exercise (CORTEX)-II With Middle-Aged Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Keywords: adherence
cognition
exercise
aging
brain training
cognitive training
executive function
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-04-24
Enrollment: 233
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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 \[TICS\])

Exclusion Criteria:

* 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

Primary outcomes:
measure: Exercise self-regulation
timeFrame: 12 months
Secondary outcomes:
measure: Dual task functioning (change)
timeFrame: 1 month
measure: Memory functioning (change)
timeFrame: 1 month
measure: Exercise self-efficacy (change)
timeFrame: 1 month
measure: Physical activity self-regulatory strategy-use (change)
timeFrame: 1 month
measure: Exercise planning (change)
timeFrame: 1 month
measure: Memory strategy-use (change)
timeFrame: 1 month
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sean P Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
References: