Mindfulness-Based Stress Reduction, Health Education and Exercise

Age-related Cognitive Decline Clinical Trial

— MEDEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665481
• Other study ID #: 201410093
• Secondary ID: 1R01AG049369-01
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 2021

Study information

• Verified date: September 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: May 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• MBSR

• Exercise

• Health Education

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California San Diego	San Diego	California

Sponsors (6)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA), National Institutes of Health (NIH), The Brain Research Foundation, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory Composite Score	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.	Month 0, Month 3, Month 6, and Month 18
Primary	Cognitive Control Composite Score	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.	Month 0, Month 3, Month 6, Month 18
Secondary	Hippocampal Volume	The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.	Month 0, Month 6, Month 18
Secondary	DLPFC Surface Area	The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.	Month 0, Month 6, Month 18
Secondary	DLPFC Cortical Thickness	The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.	Month 0, Month 6, and Month 18
Secondary	OTDL (Observed Tasks of Daily Living).	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.	Month 0, Month 6, Month 18
Secondary	Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).	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.	Month 0, Month 3, Month 6, Month 18

External Links

•   Visit the Healthy Mind Lab for more information about the MEDEX study and our other areas of research. STL: http://healthymind.wustl.edu/medex UCSD: http://www.medexstudy.com/