Clinical trial NCT02665481: Mindfulness-Based Stress Reduction, Health Education and Exercise
Official title: Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Keywords: Exercise
Mindfulness
Education
Elderly
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
name: National Center for Complementary and Integrative Health (NCCIH)
name: The Brain Research Foundation
First posted: 2016-01-27
Enrollment: 585
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Memory Composite Score
timeFrame: Month 0, Month 3, Month 6, and Month 18
measure: Cognitive Control Composite Score
timeFrame: Month 0, Month 3, Month 6, Month 18
Secondary outcomes:
measure: Hippocampal Volume
timeFrame: Month 0, Month 6, Month 18
measure: DLPFC Surface Area
timeFrame: Month 0, Month 6, Month 18
measure: DLPFC Cortical Thickness
timeFrame: Month 0, Month 6, and Month 18
measure: OTDL (Observed Tasks of Daily Living).
timeFrame: Month 0, Month 6, Month 18
measure: Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
timeFrame: Month 0, Month 3, Month 6, Month 18
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Eric J Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References: