Mindfulness-Based Stress Reduction, Health Education and Exercise (MEDEX)
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| ClinicalTrials.gov Identifier: NCT02665481 |
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Recruitment Status :
Completed
First Posted : January 27, 2016
Results First Posted : September 28, 2022
Last Update Posted : September 28, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Age-related Cognitive Decline | Behavioral: MBSR Behavioral: Exercise Behavioral: Health Education | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 585 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise |
| Actual Study Start Date : | April 2015 |
| Actual Primary Completion Date : | June 2020 |
| Actual Study Completion Date : | May 2021 |
| 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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Behavioral: MBSR
Other Name: Mindfulness-Based Stress Reduction |
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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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Behavioral: Exercise
Other Name: Multi-component intensity-based exercise |
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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). |
Behavioral: MBSR
Other Name: Mindfulness-Based Stress Reduction Behavioral: Exercise Other Name: Multi-component intensity-based exercise |
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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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Behavioral: Health Education |
- Memory Composite Score [ Time Frame: Month 0, Month 3, Month 6, and Month 18 ]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.
- Cognitive Control Composite Score [ Time Frame: Month 0, Month 3, Month 6, Month 18 ]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.
- Hippocampal Volume [ Time Frame: Month 0, Month 6, Month 18 ]The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
- DLPFC Surface Area [ Time Frame: Month 0, Month 6, Month 18 ]The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
- DLPFC Cortical Thickness [ Time Frame: Month 0, Month 6, and Month 18 ]The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
- OTDL (Observed Tasks of Daily Living). [ Time Frame: Month 0, Month 6, Month 18 ]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.
- Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). [ Time Frame: Month 0, Month 3, Month 6, Month 18 ]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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| Ages Eligible for Study: | 65 Years to 84 Years (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665481
| United States, California | |
| University of California San Diego | |
| San Diego, California, United States, 92122 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Eric J Lenze, MD | Washington University School of Medicine |
Documents provided by Washington University School of Medicine:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT02665481 |
| Other Study ID Numbers: |
201410093 1R01AG049369-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2016 Key Record Dates |
| Results First Posted: | September 28, 2022 |
| Last Update Posted: | September 28, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available for release upon request to qualified investigators. |
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Exercise Mindfulness Education Elderly |
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Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |