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

NCT ID: NCT05124132

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-related Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type BEHAVIORAL

Mindfulness-Based Stress Reduction

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Exercise

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.

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction + Exercise

Intervention Type BEHAVIORAL

Mindfulness-Based Stress Reduction + Exercise

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.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Health Education

Interventions

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Mindfulness-Based Stress Reduction

Mindfulness-Based Stress Reduction

Intervention Type BEHAVIORAL

Exercise

Exercise

Intervention Type BEHAVIORAL

Mindfulness-Based Stress Reduction + Exercise

Mindfulness-Based Stress Reduction + Exercise

Intervention Type BEHAVIORAL

Health Education

Health Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participated in the parent study, Protocol ID #201410093

Exclusion Criteria

* Inability to safely continue classes or complete assessments, as per PI discretion
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric J Lenze, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://healthymind.wustl.edu/medex

Visit the Healthy Mind Lab for more information about the MEDEX study and our other areas of research. STL: http://healthymind.wustl.edu/medex UCSD: http://www.medexstudy.com/

Other Identifiers

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1R01AG072694-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201810006

Identifier Type: -

Identifier Source: org_study_id

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