Cognitive Impairment, Sedentary Behavior
Conditions
Brief summary
Examine the impact of the BAILAMOS (TM) dance program on lifestyle physical activity
Detailed description
Examine the impact of the BAILAMOS (TM) dance program on lifestyle physical activity (PA). Hypothesis 1: Intervention group will demonstrate greater improvement in Lifestyle PA than controls. 2) Test the impact of BAILAMOS (TM) on cognitive function and quality of life. Hypothesis 2: Intervention group will demonstrate greater improvement in cognitive function and quality of life than controls. 3) Test the impact of BAILAMOS (TM) on brain network functional connectivity. Hypothesis 3: Intervention group will demonstrate enhanced Default Mode Network (DMN), Executive Network (EN), and sensorimotor network connectivity vis a vis controls.
Interventions
BEHAVIORALBAILAMOS©
BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Random assignment to intervention (BAILAMOS program) or control
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age \> 60 years; * Latino/Hispanic; * ability to speak Spanish; * participation in \<150 minutes/week of aerobic exercise; * adequate cognitive status as assessed by the Mini Mental State Examination (\>14/21); * danced \< 2 times/month over the past 12 months; * willingness to be randomly assigned to treatment or control group; * no plans to leave the U.S. \> two weeks during the study.
Exclusion criteria
* uncontrolled cardiovascular disease or diabetes mellitus; * pacemaker or metallic implants (infusion pumps, metal prostheses, metallic-backed transdermal patches or metallic shrapnel); - claustrophobia that precludes MRI; * stroke within the past year; * healing or unhealed fracture(s); * hip or knee replacement within the past 6 months; * heart failure; * recurrent falls within the past year; * regular use of a walker or wheelchair; * weigh more than 300 pounds, as unable to fit into MRI. The EASY (Resnick et al., 2008) will be used to learn if physician consent is needed for program enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults | Baseline and 4 months (follow up) .The 4-month post-intervention follow-up assesses average physical activity over the past 4 weeks. | Report minutes of moderate to vigorous level physical activity per week. Weekly frequency and duration of physical activity is used to calculate minutes of moderate to vigorous level physical activity (MVPA) per week. |
| Activity Counts Per Minute (CPM). | Baseline and 4 months (follow up) | Measured through a wrist-worn accelerometer (ActiGraph Model GT3X) worn for 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test | Baseline and 4 months (follow up) | Measure of executive function. The Stroop test assesses the ability to inhibit cognitive interference. Color-words are printed in inconsistent color ink. Subjects are asked to name the color of the ink and not read the word. Score range is the number of words named correctly minus errors in 30 seconds and ranges from 0-77. Higher scores reflect better performance and less interference on reading ability. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function. |
| Verbal Fluency Test - Animals | Baseline and 4 months (follow up) | This is a widely used measure of verbal fluency (or semantic memory) in which the participant is asked to generate exemplars of each of two categories (animals, fruits and vegetables) within a 60-second time limit. The primary measure of performance is the number of unique exemplars generated within the time limit. The score is the total number of animals (Animal Total) and vegetables (Vegetable Total) named within the time limit. A higher score means a better outcome. Scores range from 0 with no upper limit. |
| Symbol Digit Modalities Test | Baseline and 4 months (follow up) | Measure of the speed of perceptual processing in which the participant is asked to identify and name the numbers which belong with consecutively presented symbols for 90 seconds. The score is the number of digits correctly identified within the 90-second time limit - a higher score means a better outcome. Scores range from 0 to 110. |
| Digit Span Test - Forward | Baseline and 4 months (follow up) | This is a widely used measure of working memory (or attention) in which the participant is read number sequences of increasing length and then asked to repeat each sequence forward (Digits Forward) or backward (Digits Backward). The primary measure of performance is the number of digit sequences correctly recalled in each subpart (Digits Forward, Digits Backward). Each sequence for Digits Forward and Digits Backward is scored as error (0) or correct (1) - a higher score means a better outcome. |
| Digit Ordering Test | Baseline and 4 months (follow up) | This is a measure of working memory in which the participant is read number sequences of increasing length and is then asked to reorder the digits and say them in ascending order. Score range is 0 - 12 with a higher score meaning a better outcome. |
| Logical Memory I (Immediate) Test | Baseline and 4 months (follow up) | Measure This is a measure of memory (declarative/episodic) in which a brief story is read to P who is then asked to retell it from memory immediately (I) and after a delay (II). The primary measure of performance is the number of story units recalled. Score is the sum of story units (25) correctly recalled. Scores range from 0 - 25 with a higher score meaning a better outcome. |
| Logical Memory II (Delayed) Test | Baseline and 4 months (follow up) | Measure This is a measure of memory (declarative/episodic) in which a brief story is read to P who is then asked to retell it from memory immediately (I) and after a delay (II). The primary measure of performance is the number of story units recalled. Score is the sum of story units (25) correctly recalled. Scores range from 0 - 25 with a higher score meaning a better outcome. |
| Cerebral White Matter Volume - Global | Baseline | Assessed through magnetic resonance imaging scans |
| Cerebral White Matter Volume - Frontal | Baseline | Assessed through magnetic resonance imaging scans |
| Cerebral White Matter Volume - Temporal | Baseline | Assessed through magnetic resonance imaging scans |
| Cerebral White Matter Volume - Parietal | Baseline | Assessed through magnetic resonance imaging scans |
| Trail Making Test (TMT) Part A | Baseline and 4 months (follow up) | Measure of executive function. In part A, the subject connects a series of encircled numbers in numerical order. In part B, the subject connects encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. TMT score is the time in seconds it takes the subject to complete the test. A lower score/time is better. TMT A scores range from 0-180 seconds and TMT B scores range from 0-300 seconds. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function. |
| Cerebral White Matter Volume - Anterior Cingulate | Baseline | Assessed through magnetic resonance imaging scans |
| Cerebral White Matter Volume - Posterior Cingulate | Baseline and 4 months (follow up) | Assessed through magnetic resonance imaging scans |
| Cerebral White Matter Volume - Isthmus of the Cingulate | Baseline | Assessed through magnetic resonance imaging scans |
| Cerebral White Matter Hyper-intensities | Baseline | Assessed through magnetic resonance imaging scans |
| Cerebral Functional Connectivity - Default Mode Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Cerebral Functional Connectivity - Frontoparietal Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Cerebral Functional Connectivity - Salience Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Cerebral Functional Connectivity - Language Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Trail Making Test (TMT) Part B | Baseline and 4 months (follow up) | Measure of executive function. In part A, the subject connects a series of encircled numbers in numerical order. In part B, the subject connects encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. TMT score is the time in seconds it takes the subject to complete the test. A lower score/time is better. TMT A scores range from 0-180 seconds and TMT B scores range from 0-300 seconds. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function. |
| Verbal Fluency Test - Fruits and Vegetables | Baseline and 4 months (follow up) | This is a widely used measure of verbal fluency (or semantic memory) in which the participant is asked to generate exemplars of each of two categories (animals, fruits and vegetables) within a 60-second time limit. The primary measure of performance is the number of unique exemplars generated within the time limit. The score is the total number of animals (Animal Total) and vegetables (Vegetable Total) named within the time limit. A higher score means a better outcome. Scores range from 0 with no upper limit. |
| Digit Span Test - Backward | Baseline and 4 months (follow up) | This is a widely used measure of working memory (or attention) in which the participant is read number sequences of increasing length and then asked to repeat each sequence forward (Digits Forward) or backward (Digits Backward). The primary measure of performance is the number of digit sequences correctly recalled in each subpart (Digits Forward, Digits Backward). Each sequence for Digits Forward and Digits Backward is scored as error (0) or correct (1) - a higher score means a better outcome. |
| Cerebral White Matter Volume - Occipital | Baseline | Assessed through magnetic resonance imaging scans |
| Stroop C (Color) | Baseline and 4 months (follow up) | Measure of executive function. The Stroop test assesses the ability to inhibit cognitive interference. Color-words are printed in inconsistent color ink. Subjects are asked to name the color of the ink and not read the word. Score range is the number of words named correctly minus errors in 30 seconds and ranges from 0-77. Higher scores reflect better performance and less interference on reading ability. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BAILAMOS© BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule.
BAILAMOS©: BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule. | 12 |
| Control Randomized to wait list, received BAILAMOS© program after data collection. | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Control | Total | BAILAMOS© |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 10 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 7.18 | 67.18 years STANDARD_DEVIATION 6.42 | 67.5 years STANDARD_DEVIATION 6.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 22 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 participants | 22 participants | 12 participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 2 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Activity Counts Per Minute (CPM).
Measured through a wrist-worn accelerometer (ActiGraph Model GT3X) worn for 7 days.
Time frame: Baseline and 4 months (follow up)
Population: Complete data (pre and post) for treatment group and control group were analyzed and are presented here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAILAMOS© | Activity Counts Per Minute (CPM). | CPM per day Baseline | 13,564.14 Counts per Minute (CPM) per day | Standard Deviation 3274.16 |
| BAILAMOS© | Activity Counts Per Minute (CPM). | CPM per day Follow-up | 13,765.39 Counts per Minute (CPM) per day | Standard Deviation 3078.331 |
| Control | Activity Counts Per Minute (CPM). | CPM per day Baseline | 13,403.02 Counts per Minute (CPM) per day | — |
| Control | Activity Counts Per Minute (CPM). | CPM per day Follow-up | 14,431.7 Counts per Minute (CPM) per day | — |
Primary
Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults
Report minutes of moderate to vigorous level physical activity per week. Weekly frequency and duration of physical activity is used to calculate minutes of moderate to vigorous level physical activity (MVPA) per week.
Time frame: Baseline and 4 months (follow up) .The 4-month post-intervention follow-up assesses average physical activity over the past 4 weeks.
Population: Only participants that provided data are analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAILAMOS© | Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults | Baseline Total Leisure PA | 402.0 Minutes per week | Standard Deviation 364.8 |
| BAILAMOS© | Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults | Follow-up Total Leisure PA | 492.0 Minutes per week | Standard Deviation 241.8 |
| Control | Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults | Baseline Total Leisure PA | 315.0 Minutes per week | Standard Deviation 287.2 |
| Control | Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults | Follow-up Total Leisure PA | 326.3 Minutes per week | Standard Deviation 218.5 |
Secondary
Cerebral Functional Connectivity - Default Mode Network
Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network.
Time frame: Baseline and 4 months (follow up)
Population: A subsample of participants in MRI scans. Pre, post change for the Treatment group only was analyzed. Lack of projects funds prohibited analyses of the Control sample (n=4). However, there are plans for this Control sample to be pooled with other Control samples that are part of the same Roybal Center funding to produce a larger sample for analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral Functional Connectivity - Default Mode Network | -0.0618 Average functional connectivity |
Secondary
Cerebral Functional Connectivity - Frontoparietal Network
Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network.
Time frame: Baseline and 4 months (follow up)
Population: A subsample of participants in MRI scans. Pre, post change for the Treatment group only was analyzed. Lack of projects funds prohibited analyses of the Control sample (n=4). However, there are plans for this Control sample to be pooled with other Control samples that are part of the same Roybal Center funding to produce a larger sample for analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral Functional Connectivity - Frontoparietal Network | 0.1013 Average functional connectivity |
Secondary
Cerebral Functional Connectivity - Language Network
Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network.
Time frame: Baseline and 4 months (follow up)
Population: A subsample of participants in MRI scans. Pre, post change for the treatment group only was analyzed. Lack of projects funds prohibited analyses of the Control sample (n=4). However, there are plans for this Control sample to be pooled with other Control samples that are part of the same Roybal Center funding to produce a larger sample for analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral Functional Connectivity - Language Network | 0.0394 Average functional connectivity |
Secondary
Cerebral Functional Connectivity - Salience Network
Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the networks.nii (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network.
Time frame: Baseline and 4 months (follow up)
Population: A subsample of participants in MRI scans. Pre, post change for the Treatment group only was analyzed. Lack of projects funds prohibited analyses of the Control sample (n=4). However, there are plans for this Control sample to be pooled with other Control samples that are part of the same Roybal Center funding to produce a larger sample for analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral Functional Connectivity - Salience Network | -0.0422 Average functional connectivity |
Secondary
Cerebral White Matter Hyper-intensities
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BAILAMOS© | Cerebral White Matter Hyper-intensities | 1728.66 Cubic millimeters | Standard Deviation 1194.1 |
| Control | Cerebral White Matter Hyper-intensities | 2567.49 Cubic millimeters | Standard Deviation 782.4 |
Secondary
Cerebral White Matter Volume - Anterior Cingulate
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Anterior Cingulate | 9,596.52 Cubic millimeters | — |
| Control | Cerebral White Matter Volume - Anterior Cingulate | 9,099.53 Cubic millimeters | Standard Deviation 618.19 |
Secondary
Cerebral White Matter Volume - Frontal
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Frontal | 130,416.27 Cubic millimeters |
| Control | Cerebral White Matter Volume - Frontal | 128,372.50 Cubic millimeters |
Secondary
Cerebral White Matter Volume - Global
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Global | 417,408.33 Cubic millimeters |
| Control | Cerebral White Matter Volume - Global | 405,458.70 Cubic millimeters |
Secondary
Cerebral White Matter Volume - Isthmus of the Cingulate
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Isthmus of the Cingulate | 6,578.39 Cubic millimeters | — |
| Control | Cerebral White Matter Volume - Isthmus of the Cingulate | 6,625.83 Cubic millimeters | Standard Deviation 685.92 |
Secondary
Cerebral White Matter Volume - Occipital
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Occipital | 42,533.23 Cubic millimeters |
| Control | Cerebral White Matter Volume - Occipital | 40,715.26 Cubic millimeters |
Secondary
Cerebral White Matter Volume - Parietal
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Parietal | 67,813.37 Cubic millimeters |
| Control | Cerebral White Matter Volume - Parietal | 68,110.53 Cubic millimeters |
Secondary
Cerebral White Matter Volume - Posterior Cingulate
Assessed through magnetic resonance imaging scans
Time frame: Baseline and 4 months (follow up)
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Posterior Cingulate | 8,326.62 Cubic millimeters | — |
| Control | Cerebral White Matter Volume - Posterior Cingulate | 7,850.10 Cubic millimeters | Standard Deviation 874.68 |
Secondary
Cerebral White Matter Volume - Temporal
Assessed through magnetic resonance imaging scans
Time frame: Baseline
Population: A subsample of 14 participants participated in MRI scans. We analyzed and published baseline data for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Cerebral White Matter Volume - Temporal | 38,062.08 Cubic millimeters |
| Control | Cerebral White Matter Volume - Temporal | 37,748.52 Cubic millimeters |
Secondary
Digit Ordering Test
This is a measure of working memory in which the participant is read number sequences of increasing length and is then asked to reorder the digits and say them in ascending order. Score range is 0 - 12 with a higher score meaning a better outcome.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Digit Ordering Test | 0.17 score on a scale |
| Control | Digit Ordering Test | 1.40 score on a scale |
Secondary
Digit Span Test - Backward
This is a widely used measure of working memory (or attention) in which the participant is read number sequences of increasing length and then asked to repeat each sequence forward (Digits Forward) or backward (Digits Backward). The primary measure of performance is the number of digit sequences correctly recalled in each subpart (Digits Forward, Digits Backward). Each sequence for Digits Forward and Digits Backward is scored as error (0) or correct (1) - a higher score means a better outcome.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Digit Span Test - Backward | 0.33 score on a scale |
| Control | Digit Span Test - Backward | -0.20 score on a scale |
Secondary
Digit Span Test - Forward
This is a widely used measure of working memory (or attention) in which the participant is read number sequences of increasing length and then asked to repeat each sequence forward (Digits Forward) or backward (Digits Backward). The primary measure of performance is the number of digit sequences correctly recalled in each subpart (Digits Forward, Digits Backward). Each sequence for Digits Forward and Digits Backward is scored as error (0) or correct (1) - a higher score means a better outcome.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Digit Span Test - Forward | 0.25 score on a scale |
| Control | Digit Span Test - Forward | -0.20 score on a scale |
Secondary
Logical Memory II (Delayed) Test
Measure This is a measure of memory (declarative/episodic) in which a brief story is read to P who is then asked to retell it from memory immediately (I) and after a delay (II). The primary measure of performance is the number of story units recalled. Score is the sum of story units (25) correctly recalled. Scores range from 0 - 25 with a higher score meaning a better outcome.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Logical Memory II (Delayed) Test | -0.83 score on a scale |
| Control | Logical Memory II (Delayed) Test | 1.40 score on a scale |
Secondary
Logical Memory I (Immediate) Test
Measure This is a measure of memory (declarative/episodic) in which a brief story is read to P who is then asked to retell it from memory immediately (I) and after a delay (II). The primary measure of performance is the number of story units recalled. Score is the sum of story units (25) correctly recalled. Scores range from 0 - 25 with a higher score meaning a better outcome.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Logical Memory I (Immediate) Test | -0.08 score on a scale |
| Control | Logical Memory I (Immediate) Test | 1.00 score on a scale |
Secondary
Stroop C (Color)
Measure of executive function. The Stroop test assesses the ability to inhibit cognitive interference. Color-words are printed in inconsistent color ink. Subjects are asked to name the color of the ink and not read the word. Score range is the number of words named correctly minus errors in 30 seconds and ranges from 0-77. Higher scores reflect better performance and less interference on reading ability. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Stroop C (Color) | -7.00 words |
| Control | Stroop C (Color) | -0.20 words |
Secondary
Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test
Measure of executive function. The Stroop test assesses the ability to inhibit cognitive interference. Color-words are printed in inconsistent color ink. Subjects are asked to name the color of the ink and not read the word. Score range is the number of words named correctly minus errors in 30 seconds and ranges from 0-77. Higher scores reflect better performance and less interference on reading ability. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test | -2.42 words |
| Control | Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test | 0.80 words |
Secondary
Symbol Digit Modalities Test
Measure of the speed of perceptual processing in which the participant is asked to identify and name the numbers which belong with consecutively presented symbols for 90 seconds. The score is the number of digits correctly identified within the 90-second time limit - a higher score means a better outcome. Scores range from 0 to 110.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Symbol Digit Modalities Test | 2.17 symbols |
| Control | Symbol Digit Modalities Test | 4.20 symbols |
Secondary
Trail Making Test (TMT) Part A
Measure of executive function. In part A, the subject connects a series of encircled numbers in numerical order. In part B, the subject connects encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. TMT score is the time in seconds it takes the subject to complete the test. A lower score/time is better. TMT A scores range from 0-180 seconds and TMT B scores range from 0-300 seconds. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Trail Making Test (TMT) Part A | -1.67 Seconds |
| Control | Trail Making Test (TMT) Part A | -18.20 Seconds |
Secondary
Trail Making Test (TMT) Part B
Measure of executive function. In part A, the subject connects a series of encircled numbers in numerical order. In part B, the subject connects encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. TMT score is the time in seconds it takes the subject to complete the test. A lower score/time is better. TMT A scores range from 0-180 seconds and TMT B scores range from 0-300 seconds. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Trail Making Test (TMT) Part B | -27.50 Seconds |
| Control | Trail Making Test (TMT) Part B | -3.40 Seconds |
Secondary
Verbal Fluency Test - Animals
This is a widely used measure of verbal fluency (or semantic memory) in which the participant is asked to generate exemplars of each of two categories (animals, fruits and vegetables) within a 60-second time limit. The primary measure of performance is the number of unique exemplars generated within the time limit. The score is the total number of animals (Animal Total) and vegetables (Vegetable Total) named within the time limit. A higher score means a better outcome. Scores range from 0 with no upper limit.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Verbal Fluency Test - Animals | -0.67 words |
| Control | Verbal Fluency Test - Animals | 1.00 words |
Secondary
Verbal Fluency Test - Fruits and Vegetables
This is a widely used measure of verbal fluency (or semantic memory) in which the participant is asked to generate exemplars of each of two categories (animals, fruits and vegetables) within a 60-second time limit. The primary measure of performance is the number of unique exemplars generated within the time limit. The score is the total number of animals (Animal Total) and vegetables (Vegetable Total) named within the time limit. A higher score means a better outcome. Scores range from 0 with no upper limit.
Time frame: Baseline and 4 months (follow up)
Population: Pre to post change within group for participants that completed pre and post data collection.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BAILAMOS© | Verbal Fluency Test - Fruits and Vegetables | 0.17 words |
| Control | Verbal Fluency Test - Fruits and Vegetables | 2.80 words |