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

Primary Purpose

Age-related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR
Exercise
Health Education
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cognitive Decline focused on measuring Exercise, Mindfulness, Education, Elderly

Eligibility Criteria

65 Years - 84 Years (Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of California San Diego
  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

MBSR

Exercise

MBSR + Exercise

Health Education

Arm 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.

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.

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).

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Hippocampal Volume
The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
DLPFC Surface Area
The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
DLPFC Cortical Thickness
The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
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.
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.

Full Information

First Posted
January 12, 2016
Last Updated
September 12, 2022
Sponsor
Washington University School of Medicine
Collaborators
University of California, San Diego, National Institutes of Health (NIH), National Institute on Aging (NIA), National Center for Complementary and Integrative Health (NCCIH), The Brain Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02665481
Brief Title
Mindfulness-Based Stress Reduction, Health Education and Exercise
Acronym
MEDEX
Official Title
Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of California, San Diego, National Institutes of Health (NIH), National Institute on Aging (NIA), National Center for Complementary and Integrative Health (NCCIH), The Brain Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline
Keywords
Exercise, Mindfulness, Education, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
585 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBSR
Arm Type
Experimental
Arm 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.
Arm Title
Exercise
Arm Type
Experimental
Arm 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.
Arm Title
MBSR + Exercise
Arm Type
Experimental
Arm 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).
Arm Title
Health Education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Other Intervention Name(s)
Mindfulness-Based Stress Reduction
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Multi-component intensity-based exercise
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Primary Outcome Measure Information:
Title
Memory Composite Score
Description
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.
Time Frame
Month 0, Month 3, Month 6, and Month 18
Title
Cognitive Control Composite Score
Description
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.
Time Frame
Month 0, Month 3, Month 6, Month 18
Secondary Outcome Measure Information:
Title
Hippocampal Volume
Description
The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
Time Frame
Month 0, Month 6, Month 18
Title
DLPFC Surface Area
Description
The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
Time Frame
Month 0, Month 6, Month 18
Title
DLPFC Cortical Thickness
Description
The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
Time Frame
Month 0, Month 6, and Month 18
Title
OTDL (Observed Tasks of Daily Living).
Description
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.
Time Frame
Month 0, Month 6, Month 18
Title
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Description
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.
Time Frame
Month 0, Month 3, Month 6, Month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Lenze, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available for release upon request to qualified investigators.
Links:
URL
http://healthymind.wustl.edu/medex
Description
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/

Learn more about this trial

Mindfulness-Based Stress Reduction, Health Education and Exercise

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