Sedentary BehaviorNCT04544358
iBAILA - Investigating Brains & Activity to Improve Latino Aging
A study testing BAILAMOS© in people with Sedentary Behavior and Cognitive Impairment, run by University of Illinois Chicago.
Trial summary
Examine the impact of the BAILAMOS (TM) dance program on lifestyle physical activity Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Cognitive Impairment
- What is being tested?
- BAILAMOS©
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
About this study
Examine the impact of the BAILAMOS (TM) dance program on lifestyle physical activity
Read the 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.
- Conditions
- Sedentary Behavior, Cognitive Impairment
- Being tested
- BAILAMOS©
- Medical subject headings
- Sedentary Behavior, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAILAMOS©Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BAILAMOS© | Experimental | 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. Receives: Behavioral: BAILAMOS© |
| Control | No intervention | Randomized to wait list, received BAILAMOS© program after data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 months (follow up) .The 4-month post-intervention follow-up assesses average physical activity over the past 4 weeks.
Activity Counts Per Minute (CPM).
Measured through a wrist-worn accelerometer (ActiGraph Model GT3X) worn for 7 days.
Measured: Baseline and 4 months (follow up)
Secondary outcomes (25)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
Cerebral White Matter Volume - Global
Assessed through magnetic resonance imaging scans
Measured: Baseline
Cerebral White Matter Volume - Frontal
Assessed through magnetic resonance imaging scans
Measured: Baseline
Cerebral White Matter Volume - Temporal
Assessed through magnetic resonance imaging scans
Measured: Baseline
Cerebral White Matter Volume - Parietal
Assessed through magnetic resonance imaging scans
Measured: Baseline
Cerebral White Matter Volume - Occipital
Assessed through magnetic resonance imaging scans
Measured: Baseline
Cerebral White Matter Volume - Anterior Cingulate
Assessed through magnetic resonance imaging scans
Measured: Baseline
Cerebral White Matter Volume - Posterior Cingulate
Assessed through magnetic resonance imaging scans
Measured: Baseline and 4 months (follow up)
Cerebral White Matter Volume - Isthmus of the Cingulate
Assessed through magnetic resonance imaging scans
Measured: Baseline
Cerebral White Matter Hyper-intensities
Assessed through magnetic resonance imaging scans
Measured: Baseline
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
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.
Measured: Baseline and 4 months (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Sep 2015
- Primary completion31 May 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to intervention (BAILAMOS program) or control
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Xavier Marquez, University of Illinois Chicago
- Investigators
- David X Marquez, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544358
- Sponsor's protocol ID
- 2015-0497
- Status last verified
- May 2023
- First submitted
- 31 Aug 2020
- Last updated
- 16 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iBAILA - Investigating Brains & Activity to Improve Latino Aging
- ClinicalTrials.gov ID
- NCT04544358
- Acronym / sponsor ID
- 2015-0497
- Conditions
- Sedentary Behavior, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Posted 23 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random assignment to intervention (BAILAMOS program) or control
| Arm | Type | Receives |
|---|---|---|
| BAILAMOS© | Experimental | 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. |
| Control | No intervention | –Randomized to wait list, received BAILAMOS© program after data collection. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | BAILAMOS© |
Primary outcome
Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults
Time frame: 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).
Time frame: Baseline and 4 months (follow up)
Measured through a wrist-worn accelerometer (ActiGraph Model GT3X) worn for 7 days.
25 secondary outcomes
Trail Making Test (TMT) Part A
Time frame: Baseline and 4 months (follow up)
Stroop C (Color)
Time frame: Baseline and 4 months (follow up)
Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test
Time frame: Baseline and 4 months (follow up)
Verbal Fluency Test - Animals
Time frame: Baseline and 4 months (follow up)
Symbol Digit Modalities Test
Time frame: Baseline and 4 months (follow up)
Digit Span Test - Forward
Time frame: Baseline and 4 months (follow up)
Digit Ordering Test
Time frame: Baseline and 4 months (follow up)
Logical Memory I (Immediate) Test
Time frame: Baseline and 4 months (follow up)
Logical Memory II (Delayed) Test
Time frame: Baseline and 4 months (follow up)
Cerebral White Matter Volume - Global
Time frame: Baseline
Cerebral White Matter Volume - Frontal
Time frame: Baseline
Cerebral White Matter Volume - Temporal
Time frame: Baseline
Cerebral White Matter Volume - Parietal
Time frame: Baseline
Cerebral White Matter Volume - Occipital
Time frame: Baseline
Cerebral White Matter Volume - Anterior Cingulate
Time frame: Baseline
Cerebral White Matter Volume - Posterior Cingulate
Time frame: Baseline and 4 months (follow up)
Cerebral White Matter Volume - Isthmus of the Cingulate
Time frame: Baseline
Cerebral White Matter Hyper-intensities
Time frame: Baseline
Cerebral Functional Connectivity - Default Mode Network
Time frame: Baseline and 4 months (follow up)
Cerebral Functional Connectivity - Frontoparietal Network
Time frame: Baseline and 4 months (follow up)
Cerebral Functional Connectivity - Salience Network
Time frame: Baseline and 4 months (follow up)
Cerebral Functional Connectivity - Language Network
Time frame: Baseline and 4 months (follow up)
Trail Making Test (TMT) Part B
Time frame: Baseline and 4 months (follow up)
Verbal Fluency Test - Fruits and Vegetables
Time frame: Baseline and 4 months (follow up)
Digit Span Test - Backward
Time frame: Baseline and 4 months (follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David X Marquez, PhD principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
A study testing BAILAMOS© in people with Sedentary Behavior and Cognitive Impairment, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults (time frame: Baseline and 4 months (follow up) .The 4-month post-intervention follow-up assesses average physical activity over the past 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.