Last reviewed · How we verify

NCT04544358

iBAILA - Investigating Brains & Activity to Improve Latino Aging

Completed NA Results posted Last updated 16 May 2023
What this trial tests

NA trial testing BAILAMOS© in Sedentary Behavior in 22 participants. Completed in 30 September 2016.

Timeline
1 September 2015
Primary endpoint
31 May 2016
30 September 2016

Quick facts

Lead sponsorUniversity of Illinois at Chicago
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment22
Start date1 September 2015
Primary completion31 May 2016
Estimated completion30 September 2016

Drugs / interventions tested

Conditions studied

Sponsor

University of Illinois at Chicago

Who can join

60 and older, any sex, with Sedentary Behavior or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults Primary · 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.

Baseline Total Leisure PA
GroupValue95% CI
BAILAMOS©402.0± 364.8
Control315.0± 287.2
Follow-up Total Leisure PA
GroupValue95% CI
BAILAMOS©492.0± 241.8
Control326.3± 218.5
Activity Counts Per Minute (CPM). Primary · Baseline and 4 months (follow up)

Measured through a wrist-worn accelerometer (ActiGraph Model GT3X) worn for 7 days.

CPM per day Baseline
GroupValue95% CI
BAILAMOS©13,564.14± 3274.16
Control13,403.02± 2,967.07
CPM per day Follow-up
GroupValue95% CI
BAILAMOS©13,765.39± 3078.331
Control14,431.7± 3,916.80
Trail Making Test (TMT) Part A Secondary · 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 funct

GroupValue95% CI
BAILAMOS©-1.67-15.68 – 12.35
Control-18.20-44.80 – 8.41
Stroop C (Color) Secondary · 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.

GroupValue95% CI
BAILAMOS©-7.00-13.52 – -0.47
Control-0.20-12.09 – 11.69
Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test Secondary · 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.

GroupValue95% CI
BAILAMOS©-2.42-6.56 – 1.72
Control0.80-6.46 – 8.06
Verbal Fluency Test - Animals Secondary · 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.

GroupValue95% CI
BAILAMOS©-0.67-3.11 – 1.78
Control1.000.12 – 1.88
Symbol Digit Modalities Test Secondary · 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.

GroupValue95% CI
BAILAMOS©2.170.79 – 3.54
Control4.202.36 – 6.04
Digit Span Test - Forward Secondary · 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.

GroupValue95% CI
BAILAMOS©0.25-0.93 – 1.43
Control-0.20-1.24 – 0.84
Digit Ordering Test Secondary · 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.

GroupValue95% CI
BAILAMOS©0.17-0.73 – 10.6
Control1.40-0.48 – 3.28
Logical Memory I (Immediate) Test Secondary · 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.

GroupValue95% CI
BAILAMOS©-0.08-1.42 – 1.26
Control1.00-1.92 – 3.92
Logical Memory II (Delayed) Test Secondary · 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.

GroupValue95% CI
BAILAMOS©-0.83-2.10 – 0.43
Control1.400.72 – 2.08
Cerebral White Matter Volume - Global Secondary · Baseline

Assessed through magnetic resonance imaging scans

GroupValue95% CI
BAILAMOS©417,408.33± 64,053.55
Control405,458.70± 41,940.88

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BAILAMOS©
Serious: 0/12 (0%)
Deaths: 0/12
Control While on Waitlist
Serious: 0/10 (0%)
Deaths: 0/10
Control While Participating in BAILAMOS©
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (1 terms — click to expand)

ReactionSystemBAILAMOS©Control While on WaitlistControl While Participatin…
HeadachesGeneral disorders

Data from ClinicalTrials.gov NCT04544358 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Sedentary Behavior

Currently open trials in the same condition.

Other University of Illinois at Chicago trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04544358.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing