Clinical trial NCT04544358: iBAILA - Investigating Brains & Activity to Improve Latino Aging
Official title: iBAILA - Investigating Brains & Activity to Improve Latino Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Cognitive Impairment
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment to intervention (BAILAMOS program) or control
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults
timeFrame: Baseline and 4 months (follow up) .The 4-month post-intervention follow-up assesses average physical activity over the past 4 weeks.
measure: Activity Counts Per Minute (CPM).
timeFrame: Baseline and 4 months (follow up)
Secondary outcomes:
measure: Trail Making Test (TMT) Part A
timeFrame: Baseline and 4 months (follow up)
measure: Stroop C (Color)
timeFrame: Baseline and 4 months (follow up)
measure: Stroop C-W (Color-word Test) of the Stroop Neuropsychological Screening Test
timeFrame: Baseline and 4 months (follow up)
measure: Verbal Fluency Test - Animals
timeFrame: Baseline and 4 months (follow up)
measure: Symbol Digit Modalities Test
timeFrame: Baseline and 4 months (follow up)
measure: Digit Span Test - Forward
timeFrame: Baseline and 4 months (follow up)
measure: Digit Ordering Test
timeFrame: Baseline and 4 months (follow up)
measure: Logical Memory I (Immediate) Test
timeFrame: Baseline and 4 months (follow up)
measure: Logical Memory II (Delayed) Test
timeFrame: Baseline and 4 months (follow up)
measure: Cerebral White Matter Volume - Global
timeFrame: Baseline
measure: Cerebral White Matter Volume - Frontal
timeFrame: Baseline
measure: Cerebral White Matter Volume - Temporal
timeFrame: Baseline
measure: Cerebral White Matter Volume - Parietal
timeFrame: Baseline
measure: Cerebral White Matter Volume - Occipital
timeFrame: Baseline
measure: Cerebral White Matter Volume - Anterior Cingulate
timeFrame: Baseline
measure: Cerebral White Matter Volume - Posterior Cingulate
timeFrame: Baseline and 4 months (follow up)
measure: Cerebral White Matter Volume - Isthmus of the Cingulate
timeFrame: Baseline
measure: Cerebral White Matter Hyper-intensities
timeFrame: Baseline
measure: Cerebral Functional Connectivity - Default Mode Network
timeFrame: Baseline and 4 months (follow up)
measure: Cerebral Functional Connectivity - Frontoparietal Network
timeFrame: Baseline and 4 months (follow up)
measure: Cerebral Functional Connectivity - Salience Network
timeFrame: Baseline and 4 months (follow up)
measure: Cerebral Functional Connectivity - Language Network
timeFrame: Baseline and 4 months (follow up)
measure: Trail Making Test (TMT) Part B
timeFrame: Baseline and 4 months (follow up)
measure: Verbal Fluency Test - Fruits and Vegetables
timeFrame: Baseline and 4 months (follow up)
measure: Digit Span Test - Backward
timeFrame: Baseline and 4 months (follow up)
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: David X Marquez, PhD
role: PRINCIPAL_INVESTIGATOR
References: