NCT06123182

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Feb 2024May 2027

First Submitted

Initial submission to the registry

October 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 23, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

October 27, 2023

Last Update Submit

March 23, 2026

Conditions

Keywords

AdherenceGuided Imagery

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)

EXPERIMENTAL

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 ThinkingBehavioral: Positive Affective ImageryBehavioral: HIIT Exercise Intervention

Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)

EXPERIMENTAL

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 ThinkingBehavioral: Neutral Affective ImageryBehavioral: HIIT Exercise Intervention

Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)

EXPERIMENTAL

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: Episodic Recent ThinkingBehavioral: Positive Affective ImageryBehavioral: HIIT Exercise Intervention

Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)

ACTIVE COMPARATOR

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: Episodic Recent ThinkingBehavioral: Neutral Affective ImageryBehavioral: HIIT Exercise Intervention

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.

Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI)

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

Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)

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.

Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI)Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)

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

Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)

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.

Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI)Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Study Officials

  • Laura Martin

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Brucks

CONTACT

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
Model Details: 2 (positive affect imagery vs. neutral) x 2 (episodic future thinking vs. recent thinking)
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

Locations