Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging (GETActiveHIT)

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Exercise Training
• Intervention / Treatment: Behavioral: Episodic Future Thinking; Behavioral: Positive Affective Imagery; Behavioral: Neutral Affective Imagery; Behavioral: Episodic Recent Thinking; Behavioral: HIIT Exercise Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morgan Brucks; Phone Number: (913) 588-0173; Email: mbrucks@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University Of Kansas Medical Center
      • Contact: Morgan Brucks, B.A.; Phone Number: (913) 588-0173

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI); Assigned guided imagery will be delivered during each exercise session throughout the 6-week exercise program. The guided imagery recordings will be delivered via audio recording during warm-up and cool-down periods during in-lab exercise sessions. The EFT will always be delivered during warm-up and the PAI will always be delivered during cool-down.	Behavioral: Episodic Future Thinking; During the audio recorded guided imagery exercise participants will be asked to think in detail of a future (6 months to a year) where they have made healthy choices regarding physical activity and are physically active.; Behavioral: Positive Affective Imagery; During the audio recorded guided imagery exercise participants will be asked to think in detail about the positive outcomes and sensations associated with an exercise bout.; Behavioral: HIIT Exercise Intervention; The high intensity interval training (HIIT) will be conducted 2 times per week for 6 weeks. The duration of each individual exercise session will last about 45 minutes. After the 5-minute warm-up at 30% peak workload, HIIT will consist of repeated 1-minute high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 80% of peak watts (range: 75%-85%) followed by the "off" interval at 10% of peak watts. The session will end with up to 10 minute cool-down at 20% peak workload.
Experimental: Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI); Assigned guided imagery will be delivered during each exercise session throughout the 6-week exercise program. The guided imagery recordings will be delivered via audio recording during warm-up and cool-down periods during in-lab exercise sessions. The EFT will always be delivered during warm-up and the NAI will always be delivered during cool-down.	Behavioral: Episodic Future Thinking; During the audio recorded guided imagery exercise participants will be asked to think in detail of a future (6 months to a year) where they have made healthy choices regarding physical activity and are physically active.; Behavioral: Neutral Affective Imagery; During the audio recorded guided imagery exercise participants will be asked to think in detail about the physical sensations associated with an exercise bout.; Behavioral: HIIT Exercise Intervention; The high intensity interval training (HIIT) will be conducted 2 times per week for 6 weeks. The duration of each individual exercise session will last about 45 minutes. After the 5-minute warm-up at 30% peak workload, HIIT will consist of repeated 1-minute high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 80% of peak watts (range: 75%-85%) followed by the "off" interval at 10% of peak watts. The session will end with up to 10 minute cool-down at 20% peak workload.
Experimental: Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI); Assigned guided imagery will be delivered during each exercise session throughout the 6-week exercise program. The guided imagery recordings will be delivered via audio recording during warm-up and cool-down periods during in-lab exercise sessions. The ERT will always be delivered during warm-up and the PAI will always be delivered during cool-down.	Behavioral: Positive Affective Imagery; During the audio recorded guided imagery exercise participants will be asked to think in detail about the positive outcomes and sensations associated with an exercise bout.; Behavioral: Episodic Recent Thinking; During the audio recorded guided imagery exercise participants will be asked to think about a routine weekly activity.; Behavioral: HIIT Exercise Intervention; The high intensity interval training (HIIT) will be conducted 2 times per week for 6 weeks. The duration of each individual exercise session will last about 45 minutes. After the 5-minute warm-up at 30% peak workload, HIIT will consist of repeated 1-minute high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 80% of peak watts (range: 75%-85%) followed by the "off" interval at 10% of peak watts. The session will end with up to 10 minute cool-down at 20% peak workload.
Active Comparator: Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI); Assigned guided imagery will be delivered during each exercise session throughout the 6-week exercise program. The guided imagery recordings will be delivered via audio recording during warm-up and cool-down periods during in-lab exercise sessions. The ERT will always be delivered during warm-up and the NAI will always be delivered during cool-down.	Behavioral: Neutral Affective Imagery; During the audio recorded guided imagery exercise participants will be asked to think in detail about the physical sensations associated with an exercise bout.; Behavioral: Episodic Recent Thinking; During the audio recorded guided imagery exercise participants will be asked to think about a routine weekly activity.; Behavioral: HIIT Exercise Intervention; The high intensity interval training (HIIT) will be conducted 2 times per week for 6 weeks. The duration of each individual exercise session will last about 45 minutes. After the 5-minute warm-up at 30% peak workload, HIIT will consist of repeated 1-minute high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 80% of peak watts (range: 75%-85%) followed by the "off" interval at 10% of peak watts. The session will end with up to 10 minute cool-down at 20% peak workload.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Alzheimer's Disease Risk	Genetic risk for Alzheimer's disease will be measured by examining APOE4 carrier status.	Baseline
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
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
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Laura Martin, University Of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; Guided Imagery
• Other Study ID Numbers: STUDY00150353; R33AG078087 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No