Trial Outcomes & Findings for Mindfulness-Based Stress Reduction, Health Education and Exercise (NCT NCT02665481)
NCT ID: NCT02665481
Last Updated: 2022-09-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
585 participants
Primary outcome timeframe
Month 0, Month 3, Month 6, and Month 18
Results posted on
2022-09-28
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
150
|
138
|
144
|
153
|
|
Overall Study
COMPLETED
|
139
|
119
|
106
|
111
|
|
Overall Study
NOT COMPLETED
|
11
|
19
|
38
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness-Based Stress Reduction, Health Education and Exercise
Baseline characteristics by cohort
| Measure |
MBSR
n=150 Participants
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
|
Exercise
n=138 Participants
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
|
MBSR + Exercise
n=144 Participants
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
|
Health Education
n=153 Participants
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
|
Total
n=585 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
72.4 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
71.5 years
STANDARD_DEVIATION 4.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
424 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
127 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
477 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Current smoker
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Years of education
|
16.0 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
16.6 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
16.0 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
16.1 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
16.2 years
STANDARD_DEVIATION 2.2 • n=21 Participants
|
|
APOE 4 positive
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
CIRS-G
|
6.7 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 2.8 • n=7 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 3.0 • n=4 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 2.9 • n=21 Participants
|
|
CEI
Credibility
|
30.1 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
32.9 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
26.6 units on a scale
STANDARD_DEVIATION 7.4 • n=4 Participants
|
30.6 units on a scale
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
CEI
Improvement
|
59.4 units on a scale
STANDARD_DEVIATION 24.2 • n=5 Participants
|
61.9 units on a scale
STANDARD_DEVIATION 23.5 • n=7 Participants
|
68.4 units on a scale
STANDARD_DEVIATION 23.0 • n=5 Participants
|
56.1 units on a scale
STANDARD_DEVIATION 22.5 • n=4 Participants
|
61.3 units on a scale
STANDARD_DEVIATION 23.7 • n=21 Participants
|
|
Body Mass Index (BMI) Class
Normal (16-24.9 kg/m^2)
|
57 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Body Mass Index (BMI) Class
Overweight (25-29.9 kg/m^2)
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
219 Participants
n=21 Participants
|
|
Body Mass Index (BMI) Class
Obese (30.0+ kg/m^2)
|
42 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
193 Participants
n=21 Participants
|
|
WTAR
Raw score
|
41.5 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
41.9 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
41.4 units on a scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
40.6 units on a scale
STANDARD_DEVIATION 6.9 • n=4 Participants
|
41.3 units on a scale
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
WTAR
Standard score
|
113.6 units on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
114.1 units on a scale
STANDARD_DEVIATION 10.2 • n=7 Participants
|
113.4 units on a scale
STANDARD_DEVIATION 10.4 • n=5 Participants
|
112.2 units on a scale
STANDARD_DEVIATION 10.3 • n=4 Participants
|
113.3 units on a scale
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
SPPB modified score
|
8.8 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
8.7 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 1.9 • n=21 Participants
|
|
Paragraph recall
Immediate positive total
|
43.0 units on a scale
STANDARD_DEVIATION 10.7 • n=5 Participants
|
43.4 units on a scale
STANDARD_DEVIATION 10.2 • n=7 Participants
|
41.9 units on a scale
STANDARD_DEVIATION 10.8 • n=5 Participants
|
42.6 units on a scale
STANDARD_DEVIATION 9.8 • n=4 Participants
|
42.7 units on a scale
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
Paragraph recall
Delayed positive total
|
36.4 units on a scale
STANDARD_DEVIATION 12.0 • n=5 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 10.8 • n=7 Participants
|
35.8 units on a scale
STANDARD_DEVIATION 11.3 • n=5 Participants
|
36.7 units on a scale
STANDARD_DEVIATION 10.1 • n=4 Participants
|
36.6 units on a scale
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Word list
Learning
|
32.4 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
31.3 units on a scale
STANDARD_DEVIATION 7.3 • n=7 Participants
|
31.2 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
31.1 units on a scale
STANDARD_DEVIATION 7.4 • n=4 Participants
|
31.5 units on a scale
STANDARD_DEVIATION 7.4 • n=21 Participants
|
|
Word list
Recall
|
6.9 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 3.2 • n=4 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 3.1 • n=21 Participants
|
|
Neuro-QoL cognitive function score
|
62.4 units on a scale
STANDARD_DEVIATION 12.6 • n=5 Participants
|
63.2 units on a scale
STANDARD_DEVIATION 12.1 • n=7 Participants
|
65.5 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
63.3 units on a scale
STANDARD_DEVIATION 11.4 • n=4 Participants
|
63.6 units on a scale
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
OTDL-R
|
20.7 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
20.4 units on a scale
STANDARD_DEVIATION 3.5 • n=7 Participants
|
20.3 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
20.2 units on a scale
STANDARD_DEVIATION 3.7 • n=4 Participants
|
20.4 units on a scale
STANDARD_DEVIATION 3.5 • n=21 Participants
|
|
CAMS-R
|
38.1 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
37.0 units on a scale
STANDARD_DEVIATION 5.6 • n=7 Participants
|
37.8 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
36.7 units on a scale
STANDARD_DEVIATION 5.6 • n=4 Participants
|
37.4 units on a scale
STANDARD_DEVIATION 5.9 • n=21 Participants
|
|
NIH Toolbox Fluid Cognition Composite Score
|
92.0 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
92.0 units on a scale
STANDARD_DEVIATION 10.0 • n=7 Participants
|
91.4 units on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
91.5 units on a scale
STANDARD_DEVIATION 9.1 • n=4 Participants
|
91.7 units on a scale
STANDARD_DEVIATION 9.0 • n=21 Participants
|
|
Cortisol AUC
|
5580 mcg*min/mL
STANDARD_DEVIATION 2471 • n=5 Participants
|
5703 mcg*min/mL
STANDARD_DEVIATION 2606 • n=7 Participants
|
6565 mcg*min/mL
STANDARD_DEVIATION 2950 • n=5 Participants
|
5749 mcg*min/mL
STANDARD_DEVIATION 2500 • n=4 Participants
|
5892 mcg*min/mL
STANDARD_DEVIATION 2653 • n=21 Participants
|
|
Insulin sensitivity
HOMA-IR
|
2.5 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 2.3 • n=4 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 2.1 • n=21 Participants
|
|
Insulin sensitivity
OGIS (ml*min-1*m-2)
|
352 units on a scale
STANDARD_DEVIATION 61 • n=5 Participants
|
344 units on a scale
STANDARD_DEVIATION 63 • n=7 Participants
|
348 units on a scale
STANDARD_DEVIATION 67 • n=5 Participants
|
346 units on a scale
STANDARD_DEVIATION 67 • n=4 Participants
|
348 units on a scale
STANDARD_DEVIATION 64 • n=21 Participants
|
PRIMARY outcome
Timeframe: Month 0, Month 3, Month 6, and Month 18Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
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.
Outcome measures
| Measure |
MBSR Positive
n=294 Participants
This group consists of participants that received the MBSR intervention.
|
MBSR Negative
n=291 Participants
This group consists of participants that did not receive the MBSR intervention.
|
Exercise Positive
n=282 Participants
This group consists of participants that received the Exercise intervention.
|
Exercise Negative
n=303 Participants
This group consists of participants that did not receive the Exercise intervention.
|
|---|---|---|---|---|
|
Memory Composite Score
Month 0
|
-0.11 Z-score
Standard Error 0.06
|
-0.14 Z-score
Standard Error 0.06
|
-0.13 Z-score
Standard Error 0.06
|
-0.12 Z-score
Standard Error 0.06
|
|
Memory Composite Score
Month 3
|
0.07 Z-score
Standard Error 0.06
|
0.04 Z-score
Standard Error 0.06
|
0.04 Z-score
Standard Error 0.06
|
0.06 Z-score
Standard Error 0.06
|
|
Memory Composite Score
Month 6
|
0.33 Z-score
Standard Error 0.06
|
0.34 Z-score
Standard Error 0.06
|
0.36 Z-score
Standard Error 0.07
|
0.30 Z-score
Standard Error 0.06
|
|
Memory Composite Score
Month 18
|
0.50 Z-score
Standard Error 0.06
|
0.39 Z-score
Standard Error 0.06
|
0.42 Z-score
Standard Error 0.07
|
0.47 Z-score
Standard Error 0.06
|
PRIMARY outcome
Timeframe: Month 0, Month 3, Month 6, Month 18Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
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.
Outcome measures
| Measure |
MBSR Positive
n=294 Participants
This group consists of participants that received the MBSR intervention.
|
MBSR Negative
n=291 Participants
This group consists of participants that did not receive the MBSR intervention.
|
Exercise Positive
n=282 Participants
This group consists of participants that received the Exercise intervention.
|
Exercise Negative
n=303 Participants
This group consists of participants that did not receive the Exercise intervention.
|
|---|---|---|---|---|
|
Cognitive Control Composite Score
Month 0
|
0.09 score on a scale
Standard Error 0.06
|
-0.01 score on a scale
Standard Error 0.06
|
0.05 score on a scale
Standard Error 0.06
|
0.03 score on a scale
Standard Error 0.06
|
|
Cognitive Control Composite Score
Month 3
|
0.26 score on a scale
Standard Error 0.06
|
0.21 score on a scale
Standard Error 0.06
|
0.26 score on a scale
Standard Error 0.06
|
0.21 score on a scale
Standard Error 0.06
|
|
Cognitive Control Composite Score
Month 6
|
0.48 score on a scale
Standard Error 0.06
|
0.30 score on a scale
Standard Error 0.06
|
0.44 score on a scale
Standard Error 0.06
|
0.35 score on a scale
Standard Error 0.06
|
|
Cognitive Control Composite Score
Month 18
|
0.36 score on a scale
Standard Error 0.06
|
0.30 score on a scale
Standard Error 0.06
|
0.33 score on a scale
Standard Error 0.06
|
0.32 score on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Month 0, Month 6, Month 18Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
Outcome measures
| Measure |
MBSR Positive
n=274 Participants
This group consists of participants that received the MBSR intervention.
|
MBSR Negative
n=268 Participants
This group consists of participants that did not receive the MBSR intervention.
|
Exercise Positive
n=253 Participants
This group consists of participants that received the Exercise intervention.
|
Exercise Negative
n=289 Participants
This group consists of participants that did not receive the Exercise intervention.
|
|---|---|---|---|---|
|
Hippocampal Volume
Month 18
|
3613 millimeters^3
Standard Error 21
|
3571 millimeters^3
Standard Error 22
|
3581 millimeters^3
Standard Error 22
|
3602 millimeters^3
Standard Error 21
|
|
Hippocampal Volume
Month 0
|
3680 millimeters^3
Standard Error 21
|
3618 millimeters^3
Standard Error 22
|
3641 millimeters^3
Standard Error 22
|
3656 millimeters^3
Standard Error 21
|
|
Hippocampal Volume
Month 6
|
3659 millimeters^3
Standard Error 21
|
3600 millimeters^3
Standard Error 22
|
3624 millimeters^3
Standard Error 22
|
3636 millimeters^3
Standard Error 21
|
SECONDARY outcome
Timeframe: Month 0, Month 6, Month 18Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
Outcome measures
| Measure |
MBSR Positive
n=274 Participants
This group consists of participants that received the MBSR intervention.
|
MBSR Negative
n=268 Participants
This group consists of participants that did not receive the MBSR intervention.
|
Exercise Positive
n=253 Participants
This group consists of participants that received the Exercise intervention.
|
Exercise Negative
n=289 Participants
This group consists of participants that did not receive the Exercise intervention.
|
|---|---|---|---|---|
|
DLPFC Surface Area
Month 18
|
12299 millimeters^2
Standard Error 80
|
12208 millimeters^2
Standard Error 83
|
12240 millimeters^2
Standard Error 84
|
12266 millimeters^2
Standard Error 78
|
|
DLPFC Surface Area
Month 0
|
12295 millimeters^2
Standard Error 80
|
12228 millimeters^2
Standard Error 82
|
12238 millimeters^2
Standard Error 84
|
12285 millimeters^2
Standard Error 78
|
|
DLPFC Surface Area
Month 6
|
12296 millimeters^2
Standard Error 80
|
12207 millimeters^2
Standard Error 82
|
12220 millimeters^2
Standard Error 84
|
12284 millimeters^2
Standard Error 78
|
SECONDARY outcome
Timeframe: Month 0, Month 6, and Month 18Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
Outcome measures
| Measure |
MBSR Positive
n=274 Participants
This group consists of participants that received the MBSR intervention.
|
MBSR Negative
n=268 Participants
This group consists of participants that did not receive the MBSR intervention.
|
Exercise Positive
n=253 Participants
This group consists of participants that received the Exercise intervention.
|
Exercise Negative
n=289 Participants
This group consists of participants that did not receive the Exercise intervention.
|
|---|---|---|---|---|
|
DLPFC Cortical Thickness
Month 0
|
2.77 millimeters
Standard Error 0.01
|
2.77 millimeters
Standard Error 0.01
|
2.77 millimeters
Standard Error 0.01
|
2.77 millimeters
Standard Error 0.01
|
|
DLPFC Cortical Thickness
Month 6
|
2.76 millimeters
Standard Error 0.01
|
2.76 millimeters
Standard Error 0.01
|
2.76 millimeters
Standard Error 0.01
|
2.75 millimeters
Standard Error 0.01
|
|
DLPFC Cortical Thickness
Month 18
|
2.74 millimeters
Standard Error 0.01
|
2.75 millimeters
Standard Error 0.01
|
2.74 millimeters
Standard Error 0.01
|
2.75 millimeters
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Month 0, Month 6, Month 18Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
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.
Outcome measures
| Measure |
MBSR Positive
n=294 Participants
This group consists of participants that received the MBSR intervention.
|
MBSR Negative
n=291 Participants
This group consists of participants that did not receive the MBSR intervention.
|
Exercise Positive
n=282 Participants
This group consists of participants that received the Exercise intervention.
|
Exercise Negative
n=303 Participants
This group consists of participants that did not receive the Exercise intervention.
|
|---|---|---|---|---|
|
OTDL (Observed Tasks of Daily Living).
Month 0
|
20.5 score on a scale
Standard Error 0.2
|
20.2 score on a scale
Standard Error 0.2
|
20.3 score on a scale
Standard Error 0.2
|
20.3 score on a scale
Standard Error 0.2
|
|
OTDL (Observed Tasks of Daily Living).
Month 6
|
21.7 score on a scale
Standard Error 0.2
|
21.2 score on a scale
Standard Error 0.2
|
21.3 score on a scale
Standard Error 0.2
|
21.6 score on a scale
Standard Error 0.2
|
|
OTDL (Observed Tasks of Daily Living).
Month 18
|
22.5 score on a scale
Standard Error 0.2
|
22.2 score on a scale
Standard Error 0.2
|
22.3 score on a scale
Standard Error 0.2
|
22.3 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Month 0, Month 3, Month 6, Month 18Population: modified Intent-to-Treat, which includes all participants that received at least one dose of the intervention.
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.
Outcome measures
| Measure |
MBSR Positive
n=294 Participants
This group consists of participants that received the MBSR intervention.
|
MBSR Negative
n=291 Participants
This group consists of participants that did not receive the MBSR intervention.
|
Exercise Positive
n=282 Participants
This group consists of participants that received the Exercise intervention.
|
Exercise Negative
n=303 Participants
This group consists of participants that did not receive the Exercise intervention.
|
|---|---|---|---|---|
|
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Month 0
|
64.1 score on a scale
Standard Error 0.7
|
63.0 score on a scale
Standard Error 0.7
|
64.4 score on a scale
Standard Error 0.7
|
62.8 score on a scale
Standard Error 0.7
|
|
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Month 3
|
66.8 score on a scale
Standard Error 0.7
|
66.0 score on a scale
Standard Error 0.7
|
67.0 score on a scale
Standard Error 0.7
|
65.8 score on a scale
Standard Error 0.7
|
|
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Month 6
|
68.3 score on a scale
Standard Error 0.7
|
66.3 score on a scale
Standard Error 0.7
|
67.8 score on a scale
Standard Error 0.7
|
66.8 score on a scale
Standard Error 0.7
|
|
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Month 18
|
70.0 score on a scale
Standard Error 0.7
|
67.7 score on a scale
Standard Error 0.7
|
69.9 score on a scale
Standard Error 0.8
|
67.8 score on a scale
Standard Error 0.7
|
Adverse Events
MBSR
Serious events: 18 serious events
Other events: 0 other events
Deaths: 1 deaths
Exercise
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
MBSR + Exercise
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MBSR
n=150 participants at risk
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
|
Exercise
n=138 participants at risk
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
|
MBSR + Exercise
n=144 participants at risk
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
|
Health Education
n=153 participants at risk
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
|
|---|---|---|---|---|
|
General disorders
Injury
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
2.2%
3/138 • Number of events 3 • The adverse events and serious adverse events were collected over a period of 18 months.
|
2.1%
3/144 • Number of events 3 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Cardiovascular Event
|
1.3%
2/150 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
2.9%
4/138 • Number of events 4 • The adverse events and serious adverse events were collected over a period of 18 months.
|
1.4%
2/144 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.65%
1/153 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Tumor/Cancer
|
2.7%
4/150 • Number of events 4 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
1.4%
2/144 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Bowel Obstruction
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
1.4%
2/144 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Asthma (Syncope)
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.69%
1/144 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Pneumonia
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.69%
1/144 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Blood Infection
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
1.4%
2/144 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Ocular Migraine with Aphasia
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.69%
1/144 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Viral Infection
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.65%
1/153 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Shingles/Urinary Tract Infection
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.65%
1/153 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Leg Infection
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.65%
1/153 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Pulmonary Embolism
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.65%
1/153 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Kidney Stone
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.72%
1/138 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Inflammatory Myopathy
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.72%
1/138 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Neck Pain
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.72%
1/138 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Transient Ischemic Attack (TIA)
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
1.4%
2/138 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Laminectomy
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
1.4%
2/138 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Bronchitis
|
0.00%
0/150 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.72%
1/138 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Knee Replacement Surgery
|
1.3%
2/150 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.72%
1/138 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Pancreatitis
|
1.3%
2/150 • Number of events 2 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Hip Replacement Surgery
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Diverticulitis
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Enlarged Prostate
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Kidney Failure
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
High Blood Pressure
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
|
General disorders
Death
|
0.67%
1/150 • Number of events 1 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/138 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/144 • The adverse events and serious adverse events were collected over a period of 18 months.
|
0.00%
0/153 • The adverse events and serious adverse events were collected over a period of 18 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place