Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-03-19
2027-09-20
Brief Summary
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Detailed Description
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Design and Outcomes: Adults will be consented at the beginning of visit 1. Those potentially eligible will complete MoCA, questions about previous and current medical history, and general cognitive function (visit 1). Eligibility will be confirmed at the end of visit 1. Physical fitness, and physical activity behaviors will be assessed during visit 2. Once both visits are completed, the study team will ask about attendance availability in the future. The study team will reach out following one year (or up to 3 months after the one-year mark). The participants will be asked to repeat the same procedures as visits 1 and 2 (1 year follow-up = visits 3 and 4).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult Cohort; n=100 (50 Hispanic American adults and 50 non-Hispanic American adults)
The participants in this PASOS pilot will include 50 self-identified HA individuals and 50 self-identified non-HA individuals between the ages of 55-85 years, with no psychometric evidence of neuropsychological decline. We plan to enroll an equal number of women and men. Race and ethnicity in this study will be determined via self-report or self-identification by participants.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Additional Inclusion for Hispanic Americans
* Self-identify as Hispanic American
* Report Spanish as primary language • No evidence of dementia or mild cognitive impairment based on cognitive screening \[i.e., Montreal Cognitive Assessment (MoCA) administered during Visit 1; ≥26 among non-Hispanic White, ≥25 among Hispanics, ≥24 among non-Hispanic Blacks (Milani et al., 2018)\]
Exclusion Criteria
* Artificial joint or severe disability that would make it impossible or contraindicated performing the isokinetic test
* Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
* Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate TBI, REM Behavior Sleep Disorder, untreated sleep apnea, etc.)
* Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis.
* Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months
* Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
* Use of prescribed 'memory enhancing' medications, such as Aricept or Namenda
* Previous participation in a cognitive or physical activity training study within the last 6 months or current involvement in another study involving cognitive, physical or other intervention at the time of enrollment
55 Years
85 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Locations
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University of Florida, College of Medicine-Jacksonville
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB202400815
Identifier Type: -
Identifier Source: org_study_id
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