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NCT Number: NCT06123182

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Morgan Brucks, B.A.

CONTACT

(913) 588-0173

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Episodic Future Thinking

Behavioral

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.

Episodic Recent Thinking

Behavioral

During the audio recorded guided imagery exercise participants will be asked to think about a routine weekly activity.

Positive Affective Imagery

Behavioral

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.

Neutral Affective Imagery

Behavioral

During the audio recorded guided imagery exercise participants will be asked to think in detail about the physical sensations associated with an exercise bout.

HIIT Exercise Intervention

Behavioral

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.

Primary outcomes

  1. Adherence to HIIT exercise

    Time frame: 1 to 6-weeks

    Adherence will be calculated as percent sessions attended each week and percent minutes during which the participant adhered to the HIIT protocol.

  2. The Monetary-Choice Questionnaire

    Time frame: 1 to 6-weeks

    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.

  3. Positive Affect

    Time frame: 1 to 6-weeks

    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).

Secondary outcomes

  1. Percent signal change in Functional Connectivity Neuroimaging

    Time frame: 1 to 6-weeks

    The investigators will assess % signal changes in brain connectivity between reward and regulation brain regions following intervention.

Other outcomes

  1. Number of Participants with Alzheimer's Disease Risk

    Time frame: Baseline

    Genetic risk for Alzheimer's disease will be measured by examining APOE4 carrier status.

  2. The Monetary-Choice Questionnaire

    Time frame: 1 to 12 weeks

    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.

  3. Positive Affect

    Time frame: 1 to 12 weeks

    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).

  4. Amount of Daily Moderate to Vigorous Physical Activity (MVPA minutes)

    Time frame: 1 to 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Morgan Brucks

CONTACT

[email protected]

(913) 588-0173

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging Among Mid-Life Adults: Phase II

Acronym: GETActiveHIT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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