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Behavioral Intervention

Resilience Training for Age-related Cognitive Decline (MEDEX-2 Trial)

N/A

Waitlist Available

Led By Eric J Lenze, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately three years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how stress affects cognitive function and emotional health in later life, including measures of Alzheimer Disease risk, stress, and aging.

Who is the study for?

This trial is for older adults who were part of a previous study (Protocol ID #201410093). They should be able to safely continue with classes and assessments. The focus is on those experiencing cognitive decline or stress related to the COVID-19 pandemic.

What is being tested?

The study tests how health education, mindfulness-based stress reduction, exercise, and a combination of mindfulness plus exercise can impact brain health and resilience during the pandemic among older adults.

What are the potential side effects?

While not explicitly listed, typical side effects from these interventions might include muscle soreness from exercise or temporary emotional discomfort when engaging in mindfulness practices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of the interventions on changes in cognitive performance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-Based Stress Reduction + ExerciseExperimental Treatment1 Intervention

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 II: Mindfulness-Based Stress ReductionExperimental Treatment1 Intervention

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 III: ExerciseExperimental Treatment1 Intervention

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 IV: Health EducationActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-Based Stress Reduction

2015

Completed Phase 4

~1880

Exercise

2016

Completed Phase 1

~820