Cognitive Regulation Training and Exercise Trial
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 35 - 64 |
| Updated: | 7/13/2018 |
| Start Date: | October 2016 |
| End Date: | May 2021 |
| Contact: | Shannon Parish |
| Email: | sparish2@illinois.edu |
| Phone: | 2172444502 |
Cognitive Regulation Training and Exercise (CORTEX)-II With Middle-Aged Adults
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.
(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.
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.
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.
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
We found this trial at
1
site
1409 West Green Street
Urbana, Illinois 61801
Urbana, Illinois 61801
Principal Investigator: Sean P Mullen, PhD
Phone: 217-300-7484
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