Aging Clinical Trial
— GETActiveHITOfficial title:
Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging Among Mid-Life Adults: Phase II
The goal of this behavioral clinical trial is to learn how to increase physical activity in mid-life adults. Specifically, can guided imagery that includes creating mental pictures increase excitement about working out. Participants will be asked to complete testing at the beginning of the study, following 6-weeks of an in-person exercise program, and 6-weeks after finishing the exercise program. Testing will include an exercise test, MRI, questionnaires, computer tasks, and a blood draw.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | May 2027 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 65 Years |
Eligibility | Inclusion Criteria: - speak English - have access to reliable communication (a telephone or cell phone, computer, etc.) - normal or corrected to normal vision and hearing - ambulatory (without the use of assistive devices) - physically underactive - able to give informed consent - able to exercise continuously on the recumbent stepper exercise device for 4 minutes greater than or equal to 25 watts to demonstrate ability to perform exercise on stepper & no aerobic exercise contraindications or other safety/physical concerns - able to communicate with investigators, follow 2-step command & correctly answer consent comprehension questions - stable blood pressure and statin medication doses for 30 days as these affect vascular health/hemodynamics - willing and able to safely enter magnetic resonance (MR) scanner and attempt the MR scan - willing and able to attempt a blood draw Exclusion Criteria: - patients with arrhythmias or acute cardiac events will be excluded due to potential complications with the supervised moderate exercise - at risk for hazard due to magnetic fields due to MR safety concerns - have any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder) - have history of seizures or head trauma due to MR data quality |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants with Alzheimer's Disease Risk | Genetic risk for Alzheimer's disease will be measured by examining APOE4 carrier status. | Baseline | |
Other | The Monetary-Choice Questionnaire | The Monetary-Choice Questionnaire is a 27-item self-administered questionnaire. For each item, the participant chooses between a smaller, immediate monetary reward and a larger, delayed monetary reward. The investigators will behaviorally assess participants' preferences for immediately available smaller rewards vs. delayed larger rewards. | 1 to 12 weeks | |
Other | Positive Affect | The Feeling Scale is a single item measure of core affect on which participants are asked to rate their current feelings on an 11-point scale ranging from -5 (very bad) to 5 (very good). | 1 to 12 weeks | |
Other | Amount of Daily Moderate to Vigorous Physical Activity (MVPA minutes) | The investigators will measure physical activity (MVPA minutes) at baseline, end of intervention, and end of follow-up using accelerometers worn daily for 10-14 days. | 1 to 12 weeks | |
Primary | Adherence to HIIT exercise | Adherence will be calculated as percent sessions attended each week and percent minutes during which the participant adhered to the HIIT protocol. | 1 to 6-weeks | |
Primary | The Monetary-Choice Questionnaire | The Monetary-Choice Questionnaire is a 27-item self-administered questionnaire. For each item, the participant chooses between a smaller, immediate monetary reward and a larger, delayed monetary reward. The investigators will behaviorally assess participants' preferences for immediately available smaller rewards vs. delayed larger rewards. | 1 to 6-weeks | |
Primary | Positive Affect | The Feeling Scale is a single item measure of core affect on which participants are asked to rate their current feelings on an 11-point scale ranging from -5 (very bad) to 5 (very good). | 1 to 6-weeks | |
Secondary | Percent signal change in Functional Connectivity Neuroimaging | The investigators will assess % signal changes in brain connectivity between reward and regulation brain regions following intervention. | 1 to 6-weeks |
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