Mindfulness-Based Stress Reduction, Health Education and Exercise

Not Applicable

Completed

• Conditions: Age-related Cognitive Decline
• Interventions: Behavioral: MBSR; Behavioral: Health Education; Behavioral: Exercise

• Registration Number: NCT02665481
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this research is to examine the effects of four interventions on age-related cognitive decline in healthy older adults. The investigators will examine the effects of Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based aerobic exercise, and their combination, compared to a discussion group.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Primary Completion: 2020-06
• Study Completion: 2021-05
• Results First Submitted: 2022-06-01
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-12
• Last Update Submitted: 2022-09-12
• Results First Posted: 2022-09-28
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MBSR + Exercise	MBSR	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).
Health Education	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.
MBSR + Exercise	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).
MBSR	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.
Exercise	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.

Primary Outcome Measures

Name	Time	Method
Memory Composite Score	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	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.

Secondary Outcome Measures

Name	Time	Method
OTDL (Observed Tasks of Daily Living).	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.
Hippocampal Volume	Month 0, Month 6, Month 18	The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
DLPFC Surface Area	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	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.
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).	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.

Trial Locations

Locations (2)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of California San Diego; 🇺🇸 San Diego, California, United States