Clinical trial NCT06123182: Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging
Official title: Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging Among Mid-Life Adults: Phase II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Training
Aging
Keywords: Adherence
Guided Imagery
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-11-08
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 (positive affect imagery vs. neutral) x 2 (episodic future thinking vs. recent thinking)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The proposed project will target regulation and reward systems using guided imagery to increase exercise adherence by increasing positive affect and the evaluation of future rewards among mid-life adults. The investigators will conduct a within subject design in 160 mid-life adults (45-65 years of age) and examine the impact of different components of guided imagery on exercise adherence, regulation systems indexed by delay discounting, positive affect related to exercise, and functional neuroimaging (i.e., connectivity between regulation and reward brain regions). Participants will be asked to complete three assessment appointment periods: 1) baseline, 2) 6-weeks (i.e., end of exercise intervention), and 3) 12-weeks. Each appointment will include assessment of primary outcome measures of delay discounting and exercise positive affect. In addition, baseline and 6-week appointments will include functional magnetic resonance imaging (fMRI) assessments of functional connectivity between reward and regulation regions. Physical activity will be measured at baseline, immediately following the intervention, and 6 weeks following the intervention to explore changes in physical activity across study participation. At the end of the final appointment participants will be debriefed on the goals of the study and asked to provide feedback related to feasibility, the guided imagery experience, and exercise intervention experience to inform future research. In addition, blood draws will be completed at baseline to assess genetic risk for developing Alzheimer's disease (i.e., APOE). If successful, this approach could be used in future studies to increase participation in exercise and adherence to exercise interventions with the goal of promoting brain health and reducing the risk of developing Alzheimer's disease. The design of the proposed clinical trial permits a rigorous evaluation of the role of engaging regulation and reward systems to change immediate and future reward. The exercise intervention will consist of one-on-one high intensity interval training (HIIT) overseen by an exercise specialist twice a week for 6 weeks. Exercise adherence will be monitored as the percentage of the weekly exercise and adherence to the HIIT protocol.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to HIIT exercise
timeFrame: 1 to 6-weeks
measure: The Monetary-Choice Questionnaire
timeFrame: 1 to 6-weeks
measure: Positive Affect
timeFrame: 1 to 6-weeks
Secondary outcomes:
measure: Percent signal change in Functional Connectivity Neuroimaging
timeFrame: 1 to 6-weeks
Other outcomes:
measure: Number of Participants with Alzheimer's Disease Risk
timeFrame: Baseline
measure: The Monetary-Choice Questionnaire
timeFrame: 1 to 12 weeks
measure: Positive Affect
timeFrame: 1 to 12 weeks
measure: Amount of Daily Moderate to Vigorous Physical Activity (MVPA minutes)
timeFrame: 1 to 12 weeks
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Laura Martin
role: PRINCIPAL_INVESTIGATOR
References: