Happy Older Latinos Are Active - Cognitive Decline

Not Applicable

Completed

Conditions: Cognitive Decline

Registration Number: NCT04791709

Lead Sponsor: University of Miami

Brief Summary: The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV.

Detailed Description: The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV. It assesses the feasibility of running a health promotion program, led by a community health worker (CHW) intended to help prevent cognitive decline (loss of memory and/or functioning) through a culturally tailored health promotion intervention . Eligible participants will be Latino/Hispanic individuals 50 years of age or older, living with HIV, who may be at risk of developing chronic diseases such as dementia and Alzherimer's.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

are Latino (self-identified);
are age 50+;
are HIV infected but are virologically suppressed (viral load <200 copies/mL);
volunteer informed consent

Exclusion Criteria

have diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's disease, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Telephone Interview for Cognitive Status (TICS) score less than or equal to 30;
have other conditions that could impact cognitive functioning or testing (e.g., legally blind or deaf), currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes.
have contraindications to physical activity outlined in the American College of Sports Medicine standards or severe medical illness that precludes them from safely participating in a health promotion intervention.
are unable to complete 10-meter walk test.
have plans to move outside of the Miami metropolitan area within the next 6 months or are not living in stable housing (e.g. group home).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Completing the Study	16 weeks	Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.

Secondary Outcome Measures

Name	Time	Method
Changes in Neurocognitive Impairment as Measured by the Trails Making Test	Baseline, 16 weeks	Trail Making Test (TMT). Time to accurately complete Part A and Part B. The TMT measures neurocognitive functioning and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment measured in seconds.
Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span	Baseline, 16 weeks	The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) asks participants to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each correct response earns 1 point, and the total raw score is converted to a scaled score ranging from 1 to 19. Higher scores indicate better cognitive performance; lower scores reflect increased neurocognitive impairment.
Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ)	Baseline, 16 weeks	The Global Physical Activity Questionnaire (GPAQ) scoring is based on the amount of time a person spends being physically active in a typical week. It looks at three areas: activity at work or during daily tasks (including heavy lifting, digging, carrying loads, or light activities like cleaning); traveling from place to place (like walking or cycling); and recreational activities (such as exercise, sports, or active hobbies). Each activity is converted into a standard unit called MET-minutes (Metabolic Equivalent of Task). This allows different types of activity to be compared on the same scale. The total MET-minutes per week are calculated by multiplying: Minutes per day × Days per week × MET value with higher scores indicating greater levels of activity.
Changes in Depression as Measured by the PHQ-9	Baseline, 16 weeks	The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that measures depression severity. The total score ranges from 0-27 with higher scores indicating more severe depression.
Changes in Anxiety as Measured by the GAD-7	Baseline, 16 weeks	The Generalized Anxiety Disorder (GAD-7) is a 7 item questionnaire that measures anxiety severity. The total score ranges from 0-21 with higher scores indicating more severe anxiety.
Changes in Psychosocial Functioning as Measured by the MSPSS	Baseline, 16 weeks	The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item questionnaire that measures perceived social support. The total score ranges from 1-84 with higher scores indicating more perceived social support.
Changes in Biomarkers of Cognition	Baseline, 16 weeks	Biomarkers of cognition including interleukin-15, brain derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEG-F) reported in pg/ml will be assessed from blood samples.
Changes in Biomarkers of Cognition Levels	Baseline, 16 weeks	Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.
Changes in Adiponectin	Baseline, 16 weeks	Adiponectin will be assessed from blood samples measured by ng/ml