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

NCT05124132 | Enrolling By Invitation DMC

• 2 other identifiers: 2018100061R01AG072694-01A1
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-related Cognitive Decline

Keywords

Exercise; Mindfulness; Education; Elderly

Outcome Measures

Primary Outcomes (1)

• Effects of the interventions on changes in cognitive performance

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

  Approximately three years

Study Arms (4)

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.

Behavioral: Mindfulness-Based Stress Reduction

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.

Behavioral: Exercise

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.

Behavioral: Mindfulness-Based Stress Reduction + Exercise

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.

Behavioral: Health Education

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

Mindfulness-Based Stress Reduction

Mindfulness-Based Stress Reduction

Exercise BEHAVIORAL

Exercise

Exercise

Mindfulness-Based Stress Reduction + Exercise BEHAVIORAL

Mindfulness-Based Stress Reduction + Exercise

Mindfulness-Based Stress Reduction + Exercise

Health Education BEHAVIORAL

Health Education

Health Education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participated in the parent study, Protocol ID #201410093

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of California, San Diego: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• 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/

MeSH Terms

Conditions

Motor Activity

Interventions

Mindfulness-Based Stress Reduction; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eric J Lenze, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 17, 2021
• Study Start: April 16, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)