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RECRUITING

NCT05597124

PHASE2

Exercise to Improve Brain Health in Older African Americans

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the effects of different types of exercise on brain health and Alzheimer's risk in older African Americans. Specifically, the main question\[s\] it aims to answer are: * What is the effect of a Cardio-Dance Fitness (CDF) vs. a Strength, Flexibility, and Balance (SFB) intervention on a cognitive marker of Alzheimer's risk, generalization? * What is the effect of the CDF vs. SFB intervention on a fMRI biomarker of Alzheimer's, neural flexibility, and do improvements in neural flexibility mediate improvements in generalization? * Do ABCA7 genotypic variations moderate the efficacy of the CDF vs. SFB intervention for reducing Alzheimer's risk? Participants will undergo-- at baseline and post-test-- health assessments, cognitive tests, and structural and functional magnetic resonance imaging (fMRI), and a blood-draw to assess Alzheimer's risk biomarker levels.

Official title: Determinants of Individual Differences in the Efficacy of Aerobic Exercise to Improve Brain Health and Reduce Alzheimer's Disease Risk in Older African Americans

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2023-04-20

Completion Date

2027-08-31

Last Updated

2026-02-20

Healthy Volunteers

Yes

Conditions

Aging Alzheimer Disease Healthy Aging Cognitive Change

Interventions

BEHAVIORAL

Cardio-Dance Fitness

This is an aerobic cardio-dance fitness exercise class in a social context with aerobic intensity assessed by heart rate monitoring throughout the class. Participants will meet three times a week for approximately 60 minutes per session, over 24 weeks (approximately 6 months).

BEHAVIORAL

Strength, Flexibility & Balance

This intervention will serve as a stringent, structurally equivalent, active comparator to the CDF intervention, identical in duration, frequency, and social contact except for the content of this non-aerobic intervention. SFB will involve non-aerobic activity with strength, flexibility, and balance training.

Inclusion Criteria: * self-identify as either African American or Black; * be age 60 or older; * able to speak, read, and understand English; * available over the study period; independently ambulatory (i.e., not needing a wheelchair, walker, or cane); * meet criteria for low levels of physical activity (less than 60 minutes per week) based on the International Physical Activity Questionnaire (IPAQ-short version); * scoring 28-35 (inclusive) on the Telephone Interview for Cognitive Status Modified (sensitivity \[43%\], specificity \[94%\] for lower threshold; sensitivity \[93%\], specificity \[42%\] for upper threshold)55. * scoring 20-26 (inclusive) on the Montreal Cognitive Assessment (MoCA) during the in-person screening * have clearance to participate from their primary care physician, with oversight of all our patient health under the guidance of our physician-scientist Co-I, William Hu, Chief of Cognitive Neurology at Rutgers. Exclusion Criteria: * color-blindness (because some of our tasks utilize color as a cue); * any diagnosed neurological disorder (including headaches and peripheral neuropathy); diagnosed or self-reported non-neurological conditions that likely affect MTL outcomes, such as, major depressive disorder (or a Geriatric Depression Scale-Short Form score ≥ 5), schizophrenia, delusional disorder, schizoaffective disorder or significant psychiatric symptoms that could impair the completion of the study (e.g., psychosis), substance-related and addictive disorders (or treatment in past five years), chemotherapy or radiation treatment for cancers, planning to undergo general anesthesia during the study period; * exercise contraindications, such as, orthopedic complications, myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year, current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis (DVT) or another cardiovascular event, and uncontrolled hypertension with resting systolic or diastolic blood pressures \> 180/110 mmHg.

Locations (1)

Rutgers, The State University of New Jersey - Newark campus

Newark, New Jersey, United States