Trials / Recruiting
RecruitingNCT06123182
Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging
Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging Among Mid-Life Adults: Phase II
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- All
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Episodic Recent Thinking | During the audio recorded guided imagery exercise participants will be asked to think about a routine weekly activity. |
| 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 | 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. |
Timeline
- Start date
- 2024-02-23
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2023-11-08
- Last updated
- 2026-03-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06123182. Inclusion in this directory is not an endorsement.