University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Location status: Recruiting
NCT Number: NCT06123182
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.
Interested in participating?
Request Info45 year–65 year
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
Time frame: 1 to 6-weeks
The investigators will assess % signal changes in brain connectivity between reward and regulation brain regions following intervention.
Time frame: Baseline
Genetic risk for Alzheimer's disease will be measured by examining APOE4 carrier status.
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.
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).
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.
Contact information is provided by the study sponsor or research team.
University of Kansas Medical Center
Other
Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging Among Mid-Life Adults: Phase II
Acronym: GETActiveHIT
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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