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

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Cognitive Decline	Behavioral: Mindfulness-Based Stress Reduction Behavioral: Exercise Behavioral: Mindfulness-Based Stress Reduction + Exercise Behavioral: Health Education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

468 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 16, 2019

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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
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
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

Outcome Measures

Primary Outcome Measures

Effects of the interventions on changes in cognitive performance [Approximately three years]
Test effects of mindfulness and exercise on changes in change in memory and cognitive control composites.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

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

Investigators

Principal Investigator: Eric J Lenze, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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/

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT05124132

Other Study ID Numbers:

201810006
1R01AG072694-01A1

First Posted:

Nov 17, 2021

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Washington University School of Medicine

Additional relevant MeSH terms:

COVID-19

Cognitive Dysfunction

Study Results

No Results Posted as of May 9, 2022