Cognitive Regulation Training and Exercise (NCT01837004) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Regulation Training and Exercise
United States133 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to compare CORTEX (Cognitive Regulation Training and Exercise), a multi-faceted, general and exercise-specific cognitive training program plus a 4-month exercise program, to an attention-control condition involving health and wellness informational lectures plus videos. The proposed exercise program will involve both aerobic and resistive exercises. The investigators hypothesize that pre-intervention cognitive training will enhance self-regulation and self-efficacy and in turn, increase exercise adherence. The investigators also expect more positive improvements in cognitive and psychosocial function among participants in the CORTEX condition as compared to the Control condition immediately following the cognitive booster training, and across time.
Who can participate
Age range
45 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
* between 45-64 years old at time of study
* physically inactive for the past 3 months
* have reliable access to internet
* do NOT own or play exergames (Xbox Kinect, Playstation Move, or Nintendo Wii) regularly
* do NOT engage in "brain-training" regularly
* are NOT enrolled in another exercise program or cognitive training study
* willing to be randomized
* able to participant in the full length of the 5-month study with no more than 2 consecutive weeks of vacation
Exclusion Criteria:
* \<45 or \>64 years of age at time of study
* physically active (i.e., planned 30-min walking or exercise \>2 days/wk)
* do not have reliable access to internet
* own and/or play exergames regularly (e.g., 1 day/wk)
* engage in "brain-training" regularly (e.g., Sudoku or computer game-play 1 day/wk)
* enrolled in another exercise program or cognitive training study
* cognitive impairment as defined by TICS score \<21
* depression as defined by Geriatric Depression Scale score \>5
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
1
exercise adherence
Timeframe: 4 months (from exercise intervention baseline to 4-month post-test)
2
exercise program engagement
Timeframe: 4 month period (exercise intervention start to end)