Age-related Cognitive Decline
Conditions
Keywords
Exercise, Mindfulness, Education, Elderly
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.
Interventions
BEHAVIORALMBSR
BEHAVIORALExercise
BEHAVIORALHealth Education
Sponsors
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
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Memory Composite Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DLPFC Cortical Thickness | Month 0, Month 6, and Month 18 | The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images. |
| Hippocampal Volume | Month 0, Month 6, Month 18 | The hippocampal volume is derived from structural MRI high-resolution T1-weighted images. |
| Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 0, Month 3, Month 6, Month 18 | 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. |
| OTDL (Observed Tasks of Daily Living). | Month 0, Month 6, Month 18 | 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. |
| DLPFC Surface Area | Month 0, Month 6, Month 18 | The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
MBSR | 150 |
| 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.
Exercise | 138 |
| 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).
MBSR
Exercise | 144 |
| 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.
Health Education | 153 |
| Total | 585 |
Baseline characteristics
| Characteristic | Exercise | Total | Health Education | MBSR + Exercise | MBSR |
|---|---|---|---|---|---|
| Age, Continuous | 71.1 years STANDARD_DEVIATION 4.9 | 71.5 years STANDARD_DEVIATION 4.8 | 71.1 years STANDARD_DEVIATION 4.6 | 72.4 years STANDARD_DEVIATION 5.3 | 71.2 years STANDARD_DEVIATION 4.2 |
| APOE 4 positive | 44 Participants | 174 Participants | 44 Participants | 37 Participants | 49 Participants |
| Body Mass Index (BMI) Class Normal (16-24.9 kg/m^2) | 34 Participants | 173 Participants | 47 Participants | 35 Participants | 57 Participants |
| Body Mass Index (BMI) Class Obese (30.0+ kg/m^2) | 53 Participants | 193 Participants | 52 Participants | 46 Participants | 42 Participants |
| Body Mass Index (BMI) Class Overweight (25-29.9 kg/m^2) | 51 Participants | 219 Participants | 54 Participants | 63 Participants | 51 Participants |
| CAMS-R | 37.0 units on a scale STANDARD_DEVIATION 5.6 | 37.4 units on a scale STANDARD_DEVIATION 5.9 | 36.7 units on a scale STANDARD_DEVIATION 5.6 | 37.8 units on a scale STANDARD_DEVIATION 5.9 | 38.1 units on a scale STANDARD_DEVIATION 6.2 |
| CEI Credibility | 33.5 units on a scale STANDARD_DEVIATION 5.8 | 30.6 units on a scale STANDARD_DEVIATION 7.2 | 26.6 units on a scale STANDARD_DEVIATION 7.4 | 32.9 units on a scale STANDARD_DEVIATION 6.4 | 30.1 units on a scale STANDARD_DEVIATION 6.8 |
| CEI Improvement | 61.9 units on a scale STANDARD_DEVIATION 23.5 | 61.3 units on a scale STANDARD_DEVIATION 23.7 | 56.1 units on a scale STANDARD_DEVIATION 22.5 | 68.4 units on a scale STANDARD_DEVIATION 23 | 59.4 units on a scale STANDARD_DEVIATION 24.2 |
| CIRS-G | 6.7 units on a scale STANDARD_DEVIATION 2.8 | 6.8 units on a scale STANDARD_DEVIATION 2.9 | 6.7 units on a scale STANDARD_DEVIATION 3 | 6.9 units on a scale STANDARD_DEVIATION 2.8 | 6.7 units on a scale STANDARD_DEVIATION 2.9 |
| Cortisol AUC | 5703 mcg*min/mL STANDARD_DEVIATION 2606 | 5892 mcg*min/mL STANDARD_DEVIATION 2653 | 5749 mcg*min/mL STANDARD_DEVIATION 2500 | 6565 mcg*min/mL STANDARD_DEVIATION 2950 | 5580 mcg*min/mL STANDARD_DEVIATION 2471 |
| Current smoker | 1 Participants | 10 Participants | 5 Participants | 0 Participants | 4 Participants |
| Insulin sensitivity HOMA-IR | 3.0 units on a scale STANDARD_DEVIATION 2.2 | 2.9 units on a scale STANDARD_DEVIATION 2.1 | 3.1 units on a scale STANDARD_DEVIATION 2.3 | 3.0 units on a scale STANDARD_DEVIATION 2.1 | 2.5 units on a scale STANDARD_DEVIATION 1.7 |
| Insulin sensitivity OGIS (ml*min-1*m-2) | 344 units on a scale STANDARD_DEVIATION 63 | 348 units on a scale STANDARD_DEVIATION 64 | 346 units on a scale STANDARD_DEVIATION 67 | 348 units on a scale STANDARD_DEVIATION 67 | 352 units on a scale STANDARD_DEVIATION 61 |
| Neuro-QoL cognitive function score | 63.2 units on a scale STANDARD_DEVIATION 12.1 | 63.6 units on a scale STANDARD_DEVIATION 11.9 | 63.3 units on a scale STANDARD_DEVIATION 11.4 | 65.5 units on a scale STANDARD_DEVIATION 11.4 | 62.4 units on a scale STANDARD_DEVIATION 12.6 |
| NIH Toolbox Fluid Cognition Composite Score | 92.0 units on a scale STANDARD_DEVIATION 10 | 91.7 units on a scale STANDARD_DEVIATION 9 | 91.5 units on a scale STANDARD_DEVIATION 9.1 | 91.4 units on a scale STANDARD_DEVIATION 8.4 | 92.0 units on a scale STANDARD_DEVIATION 8.7 |
| OTDL-R | 20.4 units on a scale STANDARD_DEVIATION 3.5 | 20.4 units on a scale STANDARD_DEVIATION 3.5 | 20.2 units on a scale STANDARD_DEVIATION 3.7 | 20.3 units on a scale STANDARD_DEVIATION 3.5 | 20.7 units on a scale STANDARD_DEVIATION 3.2 |
| Paragraph recall Delayed positive total | 37.5 units on a scale STANDARD_DEVIATION 10.8 | 36.6 units on a scale STANDARD_DEVIATION 11.1 | 36.7 units on a scale STANDARD_DEVIATION 10.1 | 35.8 units on a scale STANDARD_DEVIATION 11.3 | 36.4 units on a scale STANDARD_DEVIATION 12 |
| Paragraph recall Immediate positive total | 43.4 units on a scale STANDARD_DEVIATION 10.2 | 42.7 units on a scale STANDARD_DEVIATION 10.4 | 42.6 units on a scale STANDARD_DEVIATION 9.8 | 41.9 units on a scale STANDARD_DEVIATION 10.8 | 43.0 units on a scale STANDARD_DEVIATION 10.7 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 27 Participants | 5 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants | 69 Participants | 19 Participants | 18 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 9 Participants | 39 Participants | 9 Participants | 14 Participants | 7 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 4 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown/not reported | 5 Participants | 6 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 109 Participants | 477 Participants | 129 Participants | 112 Participants | 127 Participants |
| Sex: Female, Male Female | 108 Participants | 424 Participants | 106 Participants | 102 Participants | 108 Participants |
| Sex: Female, Male Male | 30 Participants | 161 Participants | 47 Participants | 42 Participants | 42 Participants |
| SPPB modified score | 8.7 units on a scale STANDARD_DEVIATION 1.9 | 8.8 units on a scale STANDARD_DEVIATION 1.9 | 8.8 units on a scale STANDARD_DEVIATION 2 | 9.0 units on a scale STANDARD_DEVIATION 2 | 8.8 units on a scale STANDARD_DEVIATION 1.8 |
| Word list Learning | 31.3 units on a scale STANDARD_DEVIATION 7.3 | 31.5 units on a scale STANDARD_DEVIATION 7.4 | 31.1 units on a scale STANDARD_DEVIATION 7.4 | 31.2 units on a scale STANDARD_DEVIATION 7.6 | 32.4 units on a scale STANDARD_DEVIATION 7.4 |
| Word list Recall | 7.1 units on a scale STANDARD_DEVIATION 3.2 | 6.8 units on a scale STANDARD_DEVIATION 3.1 | 6.5 units on a scale STANDARD_DEVIATION 3.2 | 6.6 units on a scale STANDARD_DEVIATION 3 | 6.9 units on a scale STANDARD_DEVIATION 3.1 |
| WTAR Raw score | 41.9 units on a scale STANDARD_DEVIATION 6.7 | 41.3 units on a scale STANDARD_DEVIATION 6.9 | 40.6 units on a scale STANDARD_DEVIATION 6.9 | 41.4 units on a scale STANDARD_DEVIATION 7 | 41.5 units on a scale STANDARD_DEVIATION 7.1 |
| WTAR Standard score | 114.1 units on a scale STANDARD_DEVIATION 10.2 | 113.3 units on a scale STANDARD_DEVIATION 10.4 | 112.2 units on a scale STANDARD_DEVIATION 10.3 | 113.4 units on a scale STANDARD_DEVIATION 10.4 | 113.6 units on a scale STANDARD_DEVIATION 10.6 |
| Years of education | 16.6 years STANDARD_DEVIATION 2.2 | 16.2 years STANDARD_DEVIATION 2.2 | 16.1 years STANDARD_DEVIATION 2.1 | 16.0 years STANDARD_DEVIATION 2.3 | 16.0 years STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 150 | 0 / 138 | 0 / 144 | 0 / 153 |
| other Total, other adverse events | 0 / 150 | 0 / 138 | 0 / 144 | 0 / 153 |
| serious Total, serious adverse events | 18 / 150 | 16 / 138 | 14 / 144 | 5 / 153 |
Outcome results
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.
Time frame: Month 0, Month 3, Month 6, Month 18
Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Positive | Cognitive Control Composite Score | Month 3 | 0.26 score on a scale | Standard Error 0.06 |
| MBSR Positive | Cognitive Control Composite Score | Month 0 | 0.09 score on a scale | Standard Error 0.06 |
| MBSR Positive | Cognitive Control Composite Score | Month 6 | 0.48 score on a scale | Standard Error 0.06 |
| MBSR Positive | Cognitive Control Composite Score | Month 18 | 0.36 score on a scale | Standard Error 0.06 |
| MBSR Negative | Cognitive Control Composite Score | Month 0 | -0.01 score on a scale | Standard Error 0.06 |
| MBSR Negative | Cognitive Control Composite Score | Month 6 | 0.30 score on a scale | Standard Error 0.06 |
| MBSR Negative | Cognitive Control Composite Score | Month 18 | 0.30 score on a scale | Standard Error 0.06 |
| MBSR Negative | Cognitive Control Composite Score | Month 3 | 0.21 score on a scale | Standard Error 0.06 |
| Exercise Positive | Cognitive Control Composite Score | Month 6 | 0.44 score on a scale | Standard Error 0.06 |
| Exercise Positive | Cognitive Control Composite Score | Month 3 | 0.26 score on a scale | Standard Error 0.06 |
| Exercise Positive | Cognitive Control Composite Score | Month 18 | 0.33 score on a scale | Standard Error 0.06 |
| Exercise Positive | Cognitive Control Composite Score | Month 0 | 0.05 score on a scale | Standard Error 0.06 |
| Exercise Negative | Cognitive Control Composite Score | Month 18 | 0.32 score on a scale | Standard Error 0.06 |
| Exercise Negative | Cognitive Control Composite Score | Month 6 | 0.35 score on a scale | Standard Error 0.06 |
| Exercise Negative | Cognitive Control Composite Score | Month 3 | 0.21 score on a scale | Standard Error 0.06 |
| Exercise Negative | Cognitive Control Composite Score | Month 0 | 0.03 score on a scale | Standard Error 0.06 |
Comparison: Time x MBSR (Month 0 and Month 6)p-value: 0.1295% CI: [-0.02, 0.19]Marginal Model
Comparison: Time x MBSR (Month 0 and Month 18)p-value: 0.4495% CI: [-0.15, 0.07]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 6)p-value: 0.1795% CI: [-0.03, 0.18]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 18).p-value: 0.9395% CI: [-0.12, 0.11]Marginal Model
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.
Time frame: Month 0, Month 3, Month 6, and Month 18
Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Positive | Memory Composite Score | Month 18 | 0.50 Z-score | Standard Error 0.06 |
| MBSR Positive | Memory Composite Score | Month 6 | 0.33 Z-score | Standard Error 0.06 |
| MBSR Positive | Memory Composite Score | Month 3 | 0.07 Z-score | Standard Error 0.06 |
| MBSR Positive | Memory Composite Score | Month 0 | -0.11 Z-score | Standard Error 0.06 |
| MBSR Negative | Memory Composite Score | Month 3 | 0.04 Z-score | Standard Error 0.06 |
| MBSR Negative | Memory Composite Score | Month 0 | -0.14 Z-score | Standard Error 0.06 |
| MBSR Negative | Memory Composite Score | Month 18 | 0.39 Z-score | Standard Error 0.06 |
| MBSR Negative | Memory Composite Score | Month 6 | 0.34 Z-score | Standard Error 0.06 |
| Exercise Positive | Memory Composite Score | Month 0 | -0.13 Z-score | Standard Error 0.06 |
| Exercise Positive | Memory Composite Score | Month 6 | 0.36 Z-score | Standard Error 0.07 |
| Exercise Positive | Memory Composite Score | Month 3 | 0.04 Z-score | Standard Error 0.06 |
| Exercise Positive | Memory Composite Score | Month 18 | 0.42 Z-score | Standard Error 0.07 |
| Exercise Negative | Memory Composite Score | Month 3 | 0.06 Z-score | Standard Error 0.06 |
| Exercise Negative | Memory Composite Score | Month 0 | -0.12 Z-score | Standard Error 0.06 |
| Exercise Negative | Memory Composite Score | Month 18 | 0.47 Z-score | Standard Error 0.06 |
| Exercise Negative | Memory Composite Score | Month 6 | 0.30 Z-score | Standard Error 0.06 |
Comparison: Time x MBSR (Month 0 and Month 6)p-value: 0.595% CI: [-0.15, 0.07]Marginal Model
Comparison: Time x MBSR (Month 0 and Month 18)p-value: 0.1895% CI: [-0.04, 0.19]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 6)p-value: 0.2395% CI: [-0.04, 0.17]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 18)p-value: 0.4795% CI: [-0.15, 0.07]Marginal Model
Secondary
DLPFC Cortical Thickness
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
Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Positive | DLPFC Cortical Thickness | Month 0 | 2.77 millimeters | Standard Error 0.01 |
| MBSR Positive | DLPFC Cortical Thickness | Month 18 | 2.74 millimeters | Standard Error 0.01 |
| MBSR Positive | DLPFC Cortical Thickness | Month 6 | 2.76 millimeters | Standard Error 0.01 |
| MBSR Negative | DLPFC Cortical Thickness | Month 0 | 2.77 millimeters | Standard Error 0.01 |
| MBSR Negative | DLPFC Cortical Thickness | Month 6 | 2.76 millimeters | Standard Error 0.01 |
| MBSR Negative | DLPFC Cortical Thickness | Month 18 | 2.75 millimeters | Standard Error 0.01 |
| Exercise Positive | DLPFC Cortical Thickness | Month 6 | 2.76 millimeters | Standard Error 0.01 |
| Exercise Positive | DLPFC Cortical Thickness | Month 0 | 2.77 millimeters | Standard Error 0.01 |
| Exercise Positive | DLPFC Cortical Thickness | Month 18 | 2.74 millimeters | Standard Error 0.01 |
| Exercise Negative | DLPFC Cortical Thickness | Month 18 | 2.75 millimeters | Standard Error 0.01 |
| Exercise Negative | DLPFC Cortical Thickness | Month 0 | 2.77 millimeters | Standard Error 0.01 |
| Exercise Negative | DLPFC Cortical Thickness | Month 6 | 2.75 millimeters | Standard Error 0.01 |
Comparison: Time x MBSR (Month 0 and Month 6).p-value: 0.3795% CI: [-0.02, 0.01]Marginal Model
Comparison: Time x MBSR (Month 0 and Month 18).p-value: 0.195% CI: [-0.02, 0]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 6).p-value: 0.2195% CI: [-0.004, 0.02]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 18).p-value: 0.0995% CI: [-0.02, 0]Marginal Model
Secondary
DLPFC Surface Area
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
Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Positive | DLPFC Surface Area | Month 0 | 12295 millimeters^2 | Standard Error 80 |
| MBSR Positive | DLPFC Surface Area | Month 18 | 12299 millimeters^2 | Standard Error 80 |
| MBSR Positive | DLPFC Surface Area | Month 6 | 12296 millimeters^2 | Standard Error 80 |
| MBSR Negative | DLPFC Surface Area | Month 0 | 12228 millimeters^2 | Standard Error 82 |
| MBSR Negative | DLPFC Surface Area | Month 18 | 12208 millimeters^2 | Standard Error 83 |
| MBSR Negative | DLPFC Surface Area | Month 6 | 12207 millimeters^2 | Standard Error 82 |
| Exercise Positive | DLPFC Surface Area | Month 6 | 12220 millimeters^2 | Standard Error 84 |
| Exercise Positive | DLPFC Surface Area | Month 0 | 12238 millimeters^2 | Standard Error 84 |
| Exercise Positive | DLPFC Surface Area | Month 18 | 12240 millimeters^2 | Standard Error 84 |
| Exercise Negative | DLPFC Surface Area | Month 0 | 12285 millimeters^2 | Standard Error 78 |
| Exercise Negative | DLPFC Surface Area | Month 18 | 12266 millimeters^2 | Standard Error 78 |
| Exercise Negative | DLPFC Surface Area | Month 6 | 12284 millimeters^2 | Standard Error 78 |
Comparison: Time x MBSR (Month 0 and Month 6)p-value: 0.3395% CI: [-22.95, 68.36]Marginal Model
Comparison: Time x MBSR (Month 0 and Month 18)p-value: 0.3195% CI: [-23.18, 73.88]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 6).p-value: 0.4695% CI: [-62.83, 28.48]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 18).p-value: 0.3995% CI: [-27.41, 69.64]Marginal Model
Secondary
Hippocampal Volume
The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
Time frame: Month 0, Month 6, Month 18
Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Positive | Hippocampal Volume | Month 0 | 3680 millimeters^3 | Standard Error 21 |
| MBSR Positive | Hippocampal Volume | Month 18 | 3613 millimeters^3 | Standard Error 21 |
| MBSR Positive | Hippocampal Volume | Month 6 | 3659 millimeters^3 | Standard Error 21 |
| MBSR Negative | Hippocampal Volume | Month 0 | 3618 millimeters^3 | Standard Error 22 |
| MBSR Negative | Hippocampal Volume | Month 6 | 3600 millimeters^3 | Standard Error 22 |
| MBSR Negative | Hippocampal Volume | Month 18 | 3571 millimeters^3 | Standard Error 22 |
| Exercise Positive | Hippocampal Volume | Month 6 | 3624 millimeters^3 | Standard Error 22 |
| Exercise Positive | Hippocampal Volume | Month 0 | 3641 millimeters^3 | Standard Error 22 |
| Exercise Positive | Hippocampal Volume | Month 18 | 3581 millimeters^3 | Standard Error 22 |
| Exercise Negative | Hippocampal Volume | Month 18 | 3602 millimeters^3 | Standard Error 21 |
| Exercise Negative | Hippocampal Volume | Month 6 | 3636 millimeters^3 | Standard Error 21 |
| Exercise Negative | Hippocampal Volume | Month 0 | 3656 millimeters^3 | Standard Error 21 |
Comparison: Time x MBSR (Month 0 and Month 6)p-value: 0.5395% CI: [-14.27, 7.34]Marginal Model
Comparison: Time x MBSR (Month 0 and Month 18).p-value: 0.00495% CI: [-33.88, -6.44]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 6)p-value: 0.5895% CI: [-7.76, 13.85]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 18).p-value: 0.3795% CI: [-19.98, 7.46]Marginal Model
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.
Time frame: Month 0, Month 6, Month 18
Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Positive | OTDL (Observed Tasks of Daily Living). | Month 18 | 22.5 score on a scale | Standard Error 0.2 |
| MBSR Positive | OTDL (Observed Tasks of Daily Living). | Month 0 | 20.5 score on a scale | Standard Error 0.2 |
| MBSR Positive | OTDL (Observed Tasks of Daily Living). | Month 6 | 21.7 score on a scale | Standard Error 0.2 |
| MBSR Negative | OTDL (Observed Tasks of Daily Living). | Month 6 | 21.2 score on a scale | Standard Error 0.2 |
| MBSR Negative | OTDL (Observed Tasks of Daily Living). | Month 0 | 20.2 score on a scale | Standard Error 0.2 |
| MBSR Negative | OTDL (Observed Tasks of Daily Living). | Month 18 | 22.2 score on a scale | Standard Error 0.2 |
| Exercise Positive | OTDL (Observed Tasks of Daily Living). | Month 18 | 22.3 score on a scale | Standard Error 0.2 |
| Exercise Positive | OTDL (Observed Tasks of Daily Living). | Month 0 | 20.3 score on a scale | Standard Error 0.2 |
| Exercise Positive | OTDL (Observed Tasks of Daily Living). | Month 6 | 21.3 score on a scale | Standard Error 0.2 |
| Exercise Negative | OTDL (Observed Tasks of Daily Living). | Month 6 | 21.6 score on a scale | Standard Error 0.2 |
| Exercise Negative | OTDL (Observed Tasks of Daily Living). | Month 0 | 20.3 score on a scale | Standard Error 0.2 |
| Exercise Negative | OTDL (Observed Tasks of Daily Living). | Month 18 | 22.3 score on a scale | Standard Error 0.2 |
Comparison: Time x MBSR (Month 0 and Month 6)p-value: 0.5795% CI: [-0.38, 0.69]Marginal Model
Comparison: Time x MBSR (Month 0 and Month 18).p-value: 0.9695% CI: [-0.58, 0.55]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 6).p-value: 0.3795% CI: [-0.78, 0.29]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 18).p-value: 0.9995% CI: [-0.57, 0.57]Marginal Model
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.
Time frame: Month 0, Month 3, Month 6, Month 18
Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 18 | 70.0 score on a scale | Standard Error 0.7 |
| MBSR Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 0 | 64.1 score on a scale | Standard Error 0.7 |
| MBSR Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 3 | 66.8 score on a scale | Standard Error 0.7 |
| MBSR Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 6 | 68.3 score on a scale | Standard Error 0.7 |
| MBSR Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 18 | 67.7 score on a scale | Standard Error 0.7 |
| MBSR Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 6 | 66.3 score on a scale | Standard Error 0.7 |
| MBSR Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 3 | 66.0 score on a scale | Standard Error 0.7 |
| MBSR Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 0 | 63.0 score on a scale | Standard Error 0.7 |
| Exercise Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 0 | 64.4 score on a scale | Standard Error 0.7 |
| Exercise Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 3 | 67.0 score on a scale | Standard Error 0.7 |
| Exercise Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 6 | 67.8 score on a scale | Standard Error 0.7 |
| Exercise Positive | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 18 | 69.9 score on a scale | Standard Error 0.8 |
| Exercise Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 3 | 65.8 score on a scale | Standard Error 0.7 |
| Exercise Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 0 | 62.8 score on a scale | Standard Error 0.7 |
| Exercise Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 18 | 67.8 score on a scale | Standard Error 0.7 |
| Exercise Negative | Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). | Month 6 | 66.8 score on a scale | Standard Error 0.7 |
Comparison: Time x MBSR (Month 0 and Month 6).p-value: 0.1995% CI: [-0.47, 2.33]Marginal Model
Comparison: Time x MBSR (Month 0 and Month 18).p-value: 0.0995% CI: [-0.19, 2.77]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 6).p-value: 0.4295% CI: [-1.97, 0.83]Marginal Model
Comparison: Time x Exercise (Month 0 and Month 18).p-value: 0.5495% CI: [-1.01, 1.94]Marginal Model