Exercise to Improve Brain Health in Older African Americans

NCT05597124 | Recruiting Phase 2

• 1 other identifier: Pro2022001256
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Alzheimer Disease; Healthy Aging; Cognitive Change

Outcome Measures

Primary Outcomes (3)

• Generalization Performance on the Concurrent Discrimination and Transfer Task

  The Concurrent Discrimination and Transfer Task (a task that indexes generalization, the ability to apply past learning to novel task demands) will be administered at baseline, and then following the intervention (6-months). The main outcome from this task is the number transfer errors. A higher score indicates worse generalization.

  Changes from baseline to six months

• Generalization Performance on the Acquired Equivalence Task

  The Acquired Equivalence Task (a task that indexes generalization, the ability to apply past learning to novel task demands) will be administered at baseline, and then following the intervention (6-months). The main outcome from this task is generalization accuracy. A higher score indicates better generalization.

  Changes from baseline to six months

• Medial Temporal Lobe Neural Flexibility

  Medial Temporal Lobe Neural Flexibility is a measure of synchrony via fMRI resting-state analyses in the hippocampus and other medial temporal lobe brain regions for encoding new memories. Flexibility is quantified as the number of times a node displayed a change in community assignment, normalized by the total possible number of changes; this will be computed for each of our seven regions of interest in the medial temporal lobe. A higher score indicates greater flexibility. The flexibility of the MTL network as a whole was then computed as the mean flexibility over all nodes.

  Changes from baseline to six months

Other Outcomes (4)

• Exploratory Outcome: AB 42/40

  Changes from baseline to six months

• Exploratory Outcome: p-tau181

  Changes from baseline to six months

• Exploratory Outcome: p-tau231

  Changes from baseline to six months

Study Arms (2)

Cardio-Dance Fitness

EXPERIMENTAL

This is the experimental group. Participants will meet three times a week for dance classes for approximately 60 minutes per session, over 24 weeks (approximately 6 months).

Behavioral: Cardio-Dance Fitness

Strength, Flexibility & Balance

ACTIVE COMPARATOR

This is the active control group. Participants will meet three times a week for strength, flexibility, and balance exercises for approximately 60 minutes per session, over 24 weeks (approximately 6 months).

Behavioral: Strength, Flexibility & Balance

Interventions

Cardio-Dance Fitness BEHAVIORAL

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).

Also known as: CDF

Cardio-Dance Fitness

Strength, Flexibility & Balance BEHAVIORAL

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.

Also known as: SFB

Strength, Flexibility & Balance

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Göteborg University: collaborator
• University of California, Irvine: collaborator

Study Sites (1)

Rutgers, The State University of New Jersey - Newark campus

Newark, New Jersey, 07102, United States

RECRUITING

Related Publications (1)

• Gluck MA, Gills JL, Fausto BA, Malin SK, Duberstein PR, Erickson KI, Hu L. Examining the efficacy of a cardio-dance intervention on brain health and the moderating role of ABCA7 in older African Americans: a protocol for a randomized controlled trial. Front Aging Neurosci. 2023 Nov 21;15:1266423. doi: 10.3389/fnagi.2023.1266423. eCollection 2023.

  PMID: 38076534 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Pliability

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Mark A. Gluck, PhD

  Rutgers, The State University of New Jersey - Newark campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernadette A. Fausto, PhD

CONTACT

(973) 944-0775; bernadette.fausto@rutgers.edu

Jennifer Greene, MPH

CONTACT

(973) 353-2257; jag644@rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: April 20, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: All data will be made available to share with the public after de-identification and following a grace period of six months post-grant completion to allow the PI and team to publish results from the research first.
• Access Criteria: Data requests will be approved by the Principal Investigator and Co-Investigators. Requests can be made by completing a data request form.

Locations

US (1)