Resilience and Brain Health of Older Adults During the COVID-19 Pandemic (MEDEX-2)

Purpose

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.

Condition

  • Age-related Cognitive Decline

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participated in the parent study, Protocol ID #201410093

Exclusion Criteria

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mindfulness-Based Stress Reduction 		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.
  • Behavioral: Mindfulness-Based Stress Reduction
    Mindfulness-Based Stress Reduction
  • Behavioral: Mindfulness-Based Stress Reduction + Exercise
    Mindfulness-Based Stress Reduction + Exercise
Experimental
Exercise 		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.
  • Behavioral: Exercise
    Exercise
  • Behavioral: Mindfulness-Based Stress Reduction + Exercise
    Mindfulness-Based Stress Reduction + Exercise
Experimental
Mindfulness-Based Stress Reduction + Exercise 		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.
  • Behavioral: Mindfulness-Based Stress Reduction + Exercise
    Mindfulness-Based Stress Reduction + Exercise
Active Comparator
Health Education 		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.
  • Behavioral: Health Education
    Health Education

Recruiting Locations

More Details

NCT ID
NCT05124132
Status
Enrolling by invitation
Sponsor
Washington University School of Medicine