- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02665481
Mindfulness-Based Stress Reduction, Health Education and Exercise (MEDEX)
Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
MBSR teaches mindfulness, or the focusing of attention and awareness, through various meditation techniques. Mindfulness meditation practices appear to produce neurocircuitry changes that are the reverse of those seen in age-related cognitive decline. It is widely available, acceptable to older people, and carries minimal risk of side effects or adverse events. Exercise - specifically, intense, multi-component exercise - also appears to affect brain structure and function and improve cognitive performance.
The investigators will randomize 580 non-demented healthy adults aged 65 to 84 to one of four conditions: MBSR alone, exercise alone, MBSR + exercise, or a health education discussion group control condition.
The study will consist of a 6-month acute intervention phase with weekly visits followed by a 12-month maintenance phase with weekly or monthly visits and other prompts to maintain intervention behaviors.
Assessments include cognitive tests, biomarkers, neuroimaging assessments, functional assessments to examine real-world benefits of the interventions, and other behavioral assessments to characterize participants and pave the way for further exploratory analyses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92122
- University of California San Diego
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Community-living men and women age 65 to 84.
- Self-reported cognitive complaints that are a normal part of aging.
- No current meditation practice nor prior training in it.
- Sedentary.
Exclusion Criteria:
- Known diagnosis of dementia, mild cognitive impairment, other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease), psychotic disorder, or any unstable psychiatric condition.
- Medical conditions that suggest shortened lifespan, such as metastatic cancer; or would prohibit safe participation in the interventions, including cardiovascular disease or musculoskeletal conditions; or would interfere with the assessments, such as taking medications for diabetes or ferromagnetic metal/bridgework that would interfere with MRI signal.
- IQ <70 as estimated by the Wechsler Test of Adult Reading
- Sensory impairment (language, hearing, or visual) that would prevent participation.
- Alcohol abuse within 6 months.
- Current illicit drug use.
- Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity.
- Medications that interfere with measurements, including cancer chemotherapy, glucocorticoids, and interferon.
- Inability to cooperate with protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MBSR
Mindfulness-Based Stress Reduction consists of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months.
Content includes instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life.
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Other Names:
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Experimental: Exercise
The exercise protocol is optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty.It consists 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.
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Other Names:
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Experimental: MBSR + Exercise
This condition will receive both MBSR and exercise as described above. Participants in this condition will come in once weekly to receive MBSR and twice weekly to receive exercise classes, with at-home exercise the other two days as well as daily, at-home mindfulness practice. After the initial classes participants will also attend additional weekly or monthly sessions until completion of the study. Note that at each site a pilot group is undergoing MBSR + Exercise (not randomized, separate from the RCT). |
Other Names:
Other Names:
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Active Comparator: Health Education
Health Education is a group-based intervention that increases health-related knowledge and action.
Health Education improves chronic disease management.Health Education consists of ten weekly 2.5-hour classes, followed by monthly classes for approximately 15 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory Composite Score
Time Frame: Month 0, Month 3, Month 6, and Month 18
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The memory composite variable consists of the list recall, paragraph recall, and picture sequence memory tasks.
For each memory variable, a z score is computed for each participant [(participant score - mean)/standard deviation].
Then the composite memory variable is created by averaging the z scores.
The higher the z-score, the better the outcome.
A Z-score of 0 represents the population mean.
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Month 0, Month 3, Month 6, and Month 18
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Cognitive Control Composite Score
Time Frame: Month 0, Month 3, Month 6, Month 18
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The cognitive control composite variable uses the CVOE, SART, Color Word Interference, flanker, dimensional change card sort, and list-sorting tasks.
For each cognitive variable, a z score is computed for each participant [(participant score - mean)/standard deviation].
Then the composite cognitive control variable is created by averaging the z scores.
The higher the z-score, the better the outcome.
A Z-score of 0 represents the population mean.
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Month 0, Month 3, Month 6, Month 18
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hippocampal Volume
Time Frame: Month 0, Month 6, Month 18
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The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
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Month 0, Month 6, Month 18
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DLPFC Surface Area
Time Frame: Month 0, Month 6, Month 18
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The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
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Month 0, Month 6, Month 18
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DLPFC Cortical Thickness
Time Frame: Month 0, Month 6, and Month 18
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The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
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Month 0, Month 6, and Month 18
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OTDL (Observed Tasks of Daily Living).
Time Frame: Month 0, Month 6, Month 18
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The Revised Observed Tasks of Daily Living (OTDL-R) is a performance-based test of everyday problem-solving.
Subjects completed tasks testing medication use (following medicine label directions, and completing a patient record form); telephone use (finding and dialing a number from the yellow pages); and financial management (making change with coins and bills, and balancing a checkbook).
The scores were summed with the total score having a range from 0 to 28.
The higher the score, the more likely the participant is able to complete everyday activities.
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Month 0, Month 6, Month 18
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Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Time Frame: Month 0, Month 3, Month 6, Month 18
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The Quality of Life in Neurological Disorders (NQoL) Cognitive Function Scale is an 18-item self-report measure that assesses the health-related quality of life of adults.
The total score ranges from 18 to 90 where a higher score represents a better outcome.
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Month 0, Month 3, Month 6, Month 18
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric J Lenze, MD, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201410093
- 1R01AG049369-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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