Age-related Cognitive DeclineMEDEXNCT02665481
Mindfulness-Based Stress Reduction, Health Education and Exercise
A study testing MBSR, Exercise and Health Education in people with Age-related Cognitive Decline, run by Washington University School of Medicine at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- MBSR, Exercise and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego
San Diego, California, 92122
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
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.
Read the 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.
- Conditions
- Age-related Cognitive Decline
- Being tested
- MBSR, Exercise, Health Education
- Keywords
- Exercise, Mindfulness, Education, Elderly
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Also called Mindfulness-Based Stress Reduction
ExerciseBehavioural
Also called Multi-component intensity-based exercise
Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 0, Month 3, Month 6, Month 18
Secondary outcomes (5)
Hippocampal Volume
The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
Measured: Month 0, Month 6, Month 18
DLPFC Surface Area
The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
Measured: Month 0, Month 6, Month 18
DLPFC Cortical Thickness
The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
Measured: Month 0, Month 6, and Month 18
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.
Measured: Month 0, Month 6, Month 18
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.
Measured: Month 0, Month 3, Month 6, Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2020
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Eric J Lenze, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665481
- Sponsor's protocol ID
- 201410093
- Other IDs
- 1R01AG049369-01
- Acronym
- MEDEX
- Status last verified
- Sep 2022
- First submitted
- 12 Jan 2016
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36511926
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
- ClinicalTrials.gov ID
- NCT02665481
- Acronym / sponsor ID
- MEDEX / 201410093
- Conditions
- Age-related Cognitive Decline
- Keywords
- Exercise, Mindfulness, Education, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- 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
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: MBSRMindfulness-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. |
| Exercise | Experimental | Behavioral: ExerciseThe 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. |
| MBSR + Exercise | Experimental | Behavioral: MBSR, Behavioral: ExerciseThis 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 | Active comparator | Behavioral: Health EducationHealth 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. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRAlso: Mindfulness-Based Stress Reduction | Behavioural | MBSR, MBSR + Exercise |
| ExerciseAlso: Multi-component intensity-based exercise | Behavioural | Exercise, MBSR + Exercise |
| Health Education | Behavioural | Health Education |
Primary outcome
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.
5 secondary outcomes
Hippocampal Volume
Time frame: Month 0, Month 6, Month 18
DLPFC Surface Area
Time frame: Month 0, Month 6, Month 18
DLPFC Cortical Thickness
Time frame: Month 0, Month 6, and Month 18
OTDL (Observed Tasks of Daily Living).
Time frame: Month 0, Month 6, Month 18
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Time frame: Month 0, Month 3, Month 6, Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36511926Lenze 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.
- 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/Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Lenze, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR, Exercise and Health Education in people with Age-related Cognitive Decline, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory Composite Score (time frame: Month 0, Month 3, Month 6, and Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.