Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging
GETActiveHIT
2 other identifiers
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedStudy Start
First participant enrolled
February 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 27, 2026
March 1, 2026
3.2 years
October 27, 2023
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Percent signal change in Functional Connectivity Neuroimaging
1 to 6-weeks
Other Outcomes (4)
Number of Participants with Alzheimer's Disease Risk
Baseline
The Monetary-Choice Questionnaire
1 to 12 weeks
Positive Affect
1 to 12 weeks
- +1 more other outcomes
Study Arms (4)
Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI)
EXPERIMENTALAssigned 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.
Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)
EXPERIMENTALAssigned 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.
Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)
EXPERIMENTALAssigned 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.
Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)
ACTIVE COMPARATORAssigned 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.
Interventions
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.
During the audio recorded guided imagery exercise participants will be asked to think about a routine weekly activity.
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.
During the audio recorded guided imagery exercise participants will be asked to think in detail about the physical sensations associated with an exercise bout.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Martin
University of Kansas Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Primary investigator is masked to intervention assignment. Participants are masked to the intervention - however may be able to figure out intervention based on the guided imagery content
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 27, 2023
First Posted
November 8, 2023
Study Start
February 23, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03