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Clinical Trials/NCT02665481
NCT02665481
Completed
Not Applicable

Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise

Washington University School of Medicine2 sites in 1 country585 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age-related Cognitive Decline
Sponsor
Washington University School of Medicine
Enrollment
585
Locations
2
Primary Endpoint
Memory Composite Score
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
May 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Community-living men and women age 65 to
  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • OTDL (Observed Tasks of Daily Living).(Month 0, Month 6, Month 18)
  • DLPFC Surface Area(Month 0, Month 6, Month 18)
  • Hippocampal Volume(Month 0, Month 6, Month 18)
  • DLPFC Cortical Thickness(Month 0, Month 6, and Month 18)
  • Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).(Month 0, Month 3, Month 6, Month 18)

Study Sites (2)

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