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

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ClinicalTrials.gov Identifier: NCT02665481
Recruitment Status : Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
University of California, San Diego
National Institutes of Health (NIH)
National Institute on Aging (NIA)
National Center for Complementary and Integrative Health (NCCIH)
McKnight Brain Research Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Behavioral: MBSR Behavioral: Exercise Behavioral: Health Education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
Study Start Date : April 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBSR
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
Other Name: Mindfulness-Based Stress Reduction

Experimental: Exercise
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
Other Name: Multi-component intensity-based exercise

Experimental: MBSR + Exercise

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
Other Name: Mindfulness-Based Stress Reduction

Behavioral: Exercise
Other Name: Multi-component intensity-based exercise

Active Comparator: Health Education
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



Primary Outcome Measures :
  1. Change in memory composite score [ Time Frame: Baseline (0 months), Post (6 months), Follow-up (18 months) ]
    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 summing up z scores.

  2. Change in cognitive control composite score [ Time Frame: Baseline (0 months), Post (6 months), Follow-up (18 months) ]
    The cognitive control composite variable uses the CVOE, SART, Color Word Interference, flanker, dimensional change card sort, and list-sorting tasks.


Secondary Outcome Measures :
  1. Behavioral and functional measures [ Time Frame: Baseline (0 months), Post (6 months), Follow-up (18 months) ]
    Self-report questionnaires assessed via Ecological Momentary Assessment (EMA) measuring everyday cognition, anxiety, depression, and participation in social roles and activities. The same self-report (non EMA-based) questions will be administered via standard methods to provide cross-validity checks to the EMA questions. Additionally mindfulness and sleep are measured by EMA as a process measure.

  2. Instrumental Activities of Daily Living measure [ Time Frame: Baseline (0 months), Post (6 months), Follow-up (18 months) ]
    A performance-based Instrumental Activities of Daily Living measure potentially more sensitive to intervention effect (compared to self-report).



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 84 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665481


Locations
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United States, California
University of California San Diego
San Diego, California, United States, 92122
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
University of California, San Diego
National Institutes of Health (NIH)
National Institute on Aging (NIA)
National Center for Complementary and Integrative Health (NCCIH)
McKnight Brain Research Foundation
Investigators
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Principal Investigator: Eric J Lenze, MD Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02665481     History of Changes
Other Study ID Numbers: 201410093
1R01AG049369-01 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Contact PI. Estimated date of availability December 2020.

Keywords provided by Washington University School of Medicine:
Exercise
Mindfulness
Education
Elderly

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders