CompletedNot Applicable

Cognitive Regulation Training and Exercise Trial

United States233 participantsStarted 2017-01-01

Plain-language 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.

Who can participate

Age range

35 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exercise self-regulation

Timeframe: 12 months

Trial details

NCT IDNCT03124667

SponsorUniversity of Illinois at Urbana-Champaign

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-31

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