Mindfulness-Based Stress Reduction, Health Education and Exercise

NCT02665481 | Completed Results DMC

• 2 other identifiers: 2014100931R01AG049369-01
• Study Type: interventional
• Target: 585
• Locations: 1 country
• Sites: 2

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.

Conditions

Age-related Cognitive Decline

Keywords

Exercise; Mindfulness; Education; Elderly

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Hippocampal Volume

  Month 0, Month 6, Month 18

• DLPFC Surface Area

  Month 0, Month 6, Month 18

• DLPFC Cortical Thickness

  Month 0, Month 6, and Month 18

• OTDL (Observed Tasks of Daily Living).

  Month 0, Month 6, Month 18

• Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).

  Month 0, Month 3, Month 6, Month 18

Study Arms (4)

MBSR

EXPERIMENTAL

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.

Behavioral: MBSR

Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

MBSR + Exercise

EXPERIMENTAL

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).

Behavioral: MBSR; Behavioral: Exercise

Health Education

ACTIVE COMPARATOR

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.

Behavioral: Health Education

Interventions

MBSR BEHAVIORAL

Also known as: Mindfulness-Based Stress Reduction

MBSR; MBSR + Exercise

Exercise BEHAVIORAL

Also known as: Multi-component intensity-based exercise

Exercise; MBSR + Exercise

Health Education BEHAVIORAL

Health Education

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

University of California San Diego

San Diego, California, 92122, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Lenze EJ, Voegtle M, Miller JP, Ances BM, Balota DA, Barch D, Depp CA, Diniz BS, Eyler LT, Foster ER, Gettinger TR, Head D, Hershey T, Klein S, Nichols JF, Nicol GE, Nishino T, Patterson BW, Rodebaugh TL, Schweiger J, Shimony JS, Sinacore DR, Snyder AZ, Tate S, Twamley EW, Wing D, Wu GF, Yang L, Yingling MD, Wetherell JL. Effects of Mindfulness Training and Exercise on Cognitive Function in Older Adults: A Randomized Clinical Trial. JAMA. 2022 Dec 13;328(22):2218-2229. doi: 10.1001/jama.2022.21680.

  PMID: 36511926 DERIVED

Related 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/

MeSH Terms

Conditions

Motor Activity

Interventions

Mindfulness-Based Stress Reduction; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Eric Lenze
• Organization: Washington University in St. Louis

lenzee@wustl.edu

314-362-5154

Study Officials

• Eric J Lenze, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 27, 2016
• Study Start: April 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: May 1, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)