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

Primary Purpose

Age-related Cognitive Decline

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Exercise
Mindfulness-Based Stress Reduction + Exercise
Health Education
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cognitive Decline focused on measuring Exercise, Mindfulness, Education, Elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Exercise

Mindfulness-Based Stress Reduction + Exercise

Health Education

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2021
Last Updated
June 27, 2023
Sponsor
Washington University School of Medicine
Collaborators
University of California, San Diego, National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05124132
Brief Title
Resilience and Brain Health of Older Adults During the COVID-19 Pandemic (MEDEX-2)
Acronym
MEDEX-2
Official Title
Resilience and Brain Health of Older Adults During the COVID-19 Pandemic (MEDEX-2)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of California, San Diego, National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline
Keywords
Exercise, Mindfulness, Education, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm 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.
Arm Title
Exercise
Arm Type
Experimental
Arm 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.
Arm Title
Mindfulness-Based Stress Reduction + Exercise
Arm Type
Experimental
Arm 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.
Arm Title
Health Education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Intervention Description
Mindfulness-Based Stress Reduction
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction + Exercise
Intervention Description
Mindfulness-Based Stress Reduction + Exercise
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Health Education
Primary Outcome Measure Information:
Title
Effects of the interventions on changes in cognitive performance
Description
Test effects of mindfulness and exercise on changes in change in memory and cognitive control composites.
Time Frame
Approximately three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participated in the parent study, Protocol ID #201410093 Exclusion Criteria: Inability to safely continue classes or complete assessments, as per PI discretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Lenze, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Contact PI. Estimated date of availability December 2026.
Links:
URL
http://healthymind.wustl.edu/medex
Description
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/

Learn more about this trial

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

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