iBAILA - Investigating Brains & Activity to Improve Latino Aging

Cognitive Impairment Clinical Trial

Official title:

iBAILA - Investigating Brains & Activity to Improve Latino Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544358
• Other study ID #: 2015-0497
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: May 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examine the impact of the BAILAMOS (TM) dance program on lifestyle physical activity

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Sedentary Behavior

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 4 months (follow up) .The 4-month post-intervention follow-up assesses average physical activity over the past 4 weeks.
Primary	Activity Counts Per Minute (CPM).	Measured through a wrist-worn accelerometer (ActiGraph Model GT3X) worn for 7 days.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
Secondary	Cerebral White Matter Volume - Global	Assessed through magnetic resonance imaging scans	Baseline
Secondary	Cerebral White Matter Volume - Frontal	Assessed through magnetic resonance imaging scans	Baseline
Secondary	Cerebral White Matter Volume - Temporal	Assessed through magnetic resonance imaging scans	Baseline
Secondary	Cerebral White Matter Volume - Parietal	Assessed through magnetic resonance imaging scans	Baseline
Secondary	Cerebral White Matter Volume - Occipital	Assessed through magnetic resonance imaging scans	Baseline
Secondary	Cerebral White Matter Volume - Anterior Cingulate	Assessed through magnetic resonance imaging scans	Baseline
Secondary	Cerebral White Matter Volume - Posterior Cingulate	Assessed through magnetic resonance imaging scans	Baseline and 4 months (follow up)
Secondary	Cerebral White Matter Volume - Isthmus of the Cingulate	Assessed through magnetic resonance imaging scans	Baseline
Secondary	Cerebral White Matter Hyper-intensities	Assessed through magnetic resonance imaging scans	Baseline
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)
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.	Baseline and 4 months (follow up)