iBAILA - Investigating Brains & Activity to Improve Latino Aging

NCT04544358 | Completed Results DMC

• 1 other identifier: 2015-0497
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sedentary Behavior; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (25)

• Trail Making Test (TMT) Part A

  Baseline and 4 months (follow up)

• Stroop C (Color)

  Baseline and 4 months (follow up)

• Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test

  Baseline and 4 months (follow up)

• Verbal Fluency Test - Animals

  Baseline and 4 months (follow up)

• Symbol Digit Modalities Test

  Baseline and 4 months (follow up)

Study Arms (2)

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.

Behavioral: BAILAMOS©

Control

NO INTERVENTION

Randomized to wait list, received BAILAMOS© program after data collection.

Interventions

BAILAMOS© BEHAVIORAL

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©

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Sedentary Behavior; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. David X Marquez
• Organization: University of Illinois at Chicago

marquezd@uic.edu

312.996.1209

Study Officials

• David X Marquez, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Random assignment to intervention (BAILAMOS program) or control

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2015
• Primary Completion: May 31, 2016
• Study Completion: September 30, 2016
• Last Updated: May 16, 2023
• Results First Posted: December 23, 2021

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share