Mindfulness-Based Stress Reduction, Health Education and Exercise (MEDEX)

The Washington University

Status: Completed

Conditions: Age-related Cognitive Decline

Treatments: Behavioral: Exercise; Behavioral: Health Education; Behavioral: MBSR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02665481

201410093

1R01AG049369-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 585 patients

Sex: All

Ages: 65 to 84 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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585 participants in 4 patient groups

MBSR

Experimental group

Description:

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.

Treatment:

Behavioral: MBSR

Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

MBSR + Exercise

Experimental group

Description:

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).

Treatment:

Behavioral: MBSR

Behavioral: Exercise

Health Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education