Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging Among Mid-Life Adults: Phase II
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Adherence to HIIT exercise
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI)
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.
干预措施: Episodic Future Thinking (Behavioral)
Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI)
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.
干预措施: Positive Affective Imagery (Behavioral)
Episodic Future Thinking (EFT) + Positive Affective Imagery (PAI)
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.
干预措施: HIIT Exercise Intervention (Behavioral)
Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)
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.
干预措施: Episodic Future Thinking (Behavioral)
Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)
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.
干预措施: Neutral Affective Imagery (Behavioral)
Episodic Future Thinking (EFT) + Neutral Affective Imagery (NAI)
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.
干预措施: HIIT Exercise Intervention (Behavioral)
Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)
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.
干预措施: Episodic Recent Thinking (Behavioral)
Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)
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.
干预措施: Positive Affective Imagery (Behavioral)
Episodic Recent Thinking (ERT) + Positive Affective Imagery (PAI)
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.
干预措施: HIIT Exercise Intervention (Behavioral)
Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)
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.
干预措施: HIIT Exercise Intervention (Behavioral)
Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)
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.
干预措施: Episodic Recent Thinking (Behavioral)
Episodic Recent Thinking (ERT) + Neutral Affective Imagery (NAI)
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.
干预措施: Neutral Affective Imagery (Behavioral)
结局指标
主要结局
Adherence to HIIT exercise
时间窗: 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.
The Monetary-Choice Questionnaire
时间窗: 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.
Positive Affect
时间窗: 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).
次要结局
- Percent signal change in Functional Connectivity Neuroimaging(1 to 6-weeks)
研究者
Laura Martin
Associate Professor
University of Kansas Medical Center