跳至主要内容
临床试验/NCT05124132
NCT05124132Enrolling By Invitation不适用

Resilience and Brain Health of Older Adults (MEDEX-2)

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 468 人开始时间: 2019年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
468
试验地点
2
主要终点
Effects of the interventions on changes in cognitive performance

研究概览

简要总结

This project capitalizes on a natural experiment imposed by the COVID-19 pandemic in conjunction with an extensive set of cognitive, emotional, biological, and neuroimaging variables already collected at multiple time points in older adults participating in a clinical trial of exercise and mindfulness. This project will elucidate the effects of stress on cognitive function and emotional health in later life, including biological measures of Alzheimer Disease risk, stress, and aging, with the ultimate goal of discovering how to mitigate these effects, among older adults who have made and maintained a lifestyle change.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participated in the parent study, Protocol ID #201410093

排除标准

  • Inability to safely continue classes or complete assessments, as per PI discretion

研究组 & 干预措施

Mindfulness-Based Stress Reduction + Exercise

Experimental

This condition will receive both MBSR and exercise as described. Participants in this condition will attend monthly sessions with encouragement to complete at-home mindfulness practice as well as at-home exercise for the duration of the study.

干预措施: Mindfulness-Based Stress Reduction + Exercise (Behavioral)

Mindfulness-Based Stress Reduction

Experimental

Mindfulness-Based Stress Reduction (MBSR) as delivered in the parent study (Protocol ID #201410093) consisted of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content included instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life. For the current study, participants will continue monthly approximately 2.5 hour booster sessions covering similar content for the duration of the study. Participants will be encouraged to maintain daily formal meditative activities at home.

干预措施: Mindfulness-Based Stress Reduction (Behavioral)

Exercise

Experimental

The exercise protocol in the parent study (Protocol ID #201410093) was optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty. It consisted of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months. For the current study, participants will continue monthly approximately 1.5 hour classes focused on functional training for the duration of the study. Participants will be encouraged to continue between-session engagement in aerobic and resistance training activities at home.

干预措施: Exercise (Behavioral)

Health Education

Active Comparator

The health education control condition is based on a chronic disease self-management program developed at Stanford University and was used as an attentional control in the parent study (Protocol ID #201410093). This control intervention was designed to be time-equivalent to MBSR, with 8 weeks of 2.5 hour weekly group classes followed by monthly booster sessions for approximately 15 months. For the current study, participants will continue monthly approximately 1.5 hour sessions covering similar content for the duration of the study.

干预措施: Health Education (Behavioral)

结局指标

主要结局

Effects of the interventions on changes in cognitive performance

时间窗: Approximately three years

Test effects of mindfulness and exercise on changes in change in memory and cognitive control composites.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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