Study Results
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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ENROLLING_BY_INVITATION
NA
468 participants
INTERVENTIONAL
2019-04-16
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
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.
Mindfulness-Based Stress Reduction
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.
Exercise
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.
Mindfulness-Based Stress Reduction + Exercise
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.
Health Education
Health Education
Interventions
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Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction
Exercise
Exercise
Mindfulness-Based Stress Reduction + Exercise
Mindfulness-Based Stress Reduction + Exercise
Health Education
Health Education
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
65 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
National Institutes of Health (NIH)
NIH
National Institute on Aging (NIA)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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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
Countries
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Related Links
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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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201810006
Identifier Type: -
Identifier Source: org_study_id
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