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

Aging Clinical Trial

— GETActiveHIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123182
• Other study ID #: STUDY00150353
• Secondary ID: R33AG078087
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: Morgan Brucks
• Phone: (913) 588-0173
• Email: mbrucks[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Exercise Training

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Alzheimer's Disease Risk	Genetic risk for Alzheimer's disease will be measured by examining APOE4 carrier status.	Baseline
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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