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

The Washington University

Status: Invitation-only

Conditions: Age-related Cognitive Decline

Treatments: Behavioral: Mindfulness-Based Stress Reduction + Exercise; Behavioral: Exercise; Behavioral: Health Education; Behavioral: Mindfulness-Based Stress Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05124132

1R01AG072694-01A1 (U.S. NIH Grant/Contract)

201810006

Details and patient eligibility

About

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.

Enrollment: 468 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participated in the parent study, Protocol ID #201410093

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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468 participants in 4 patient groups

Mindfulness-Based Stress Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Mindfulness-Based Stress Reduction + Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction + Exercise

Health Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education