Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
RAATE
2 other identifiers
interventional
125
1 country
1
Brief Summary
The RAATE proposal is designed to determine the effects of physical activity on risk factors for Alzheimer's Disease in older African American adults. The study will compare a physical activity program to an active control group. There are three main objectives of the protocol: 1) to determine if a physical activity intervention tailored to older African American adults is effective in modifying cognitive function associated with Alzheimer's Disease, 2) to determine if a physical activity intervention tailored to older African American adults is effective in modifying brain function and structure associated with Alzheimer's Disease, and 3) to determine if a physical activity promotion intervention tailored to African American adults is effective at enhancing physiological parameters. The primary endpoints for the study are episodic memory and executive functioning. The secondary outcomes include anthropometry, blood pressure, brain activation, cerebral blood flow, volume of whole brain and white matter hyperintensities, cardiorespiratory fitness, objectively measured physical activity, circulating hormones, and telomere length.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
August 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedNovember 25, 2024
November 1, 2024
6.2 years
March 18, 2019
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in episodic memory
The Rey Auditory Verbal Learning Test (RAVLT) is a common neuropsychological tool used to evaluate episodic memory. The RAVLT involves providing participants with 15 unrelated words and asking them to recall the word list. There are 5 trials designed to determine short-term memory and then a 30 minute delay to assess long-term memory. The total words correct in both the short- and long-term trials are used as outcome measures.
Baseline, 24 weeks, 52 weeks
Change in executive function
The NIH Toolbox Executive Function subdomain consists of the Flanker Inhibitory Control and Attention Test and the Dimensional Change Card Sort Test. The Flanker test is a measure of one's ability to inhibit attention to irrelevant conditions. Participants must identify the direction of a central visual stimuli amongst flanking stimuli either congruent or incongruent with the central stimuli. There are 40 trials and scores range from 0 - 10. The Card Sort is a measure of the ability to shift attention based on rules. Participants must match a target visual stimuli to either a color or word stimuli and this matching shifts during the assessment.
Baseline, 24 weeks, 52 weeks
Secondary Outcomes (16)
Change in cognitive status
Baseline, 24 weeks, 52 weeks
Change in glucose
Baseline, 24 weeks, 52 weeks
Change in time spent in physical activity
Baseline, 24 weeks, 52 weeks
Change in cardiorespiratory fitness
Baseline, 24 weeks, 52 weeks
Change in physical function-NIH Toolbox
Baseline, 24 weeks, 52 weeks
- +11 more secondary outcomes
Study Arms (2)
Physical activity intervention
EXPERIMENTALThe intervention group will target 150 minutes of moderate to vigorous aerobic physical activity and two days of strength training, consistent with the current physical activity recommendations. Participants will engage in 2 days per week of supervised activity at community facilities. These participants will be requested to engage in an additional 30 minutes of moderate to vigorous aerobic physical activity two days per week at home.
Active control
ACTIVE COMPARATORThe active control group will be based on a low-intensity activity program and a healthy aging educational component. The physical activities will include stretching, balance training, flexibility, relaxation, and practicing activities of daily living. The successful aging education component will cover topics including avoiding scams, fall prevention, living wills, and dementia awareness.
Interventions
Promotion of physical activity to the current federal physical activity guidelines.
Seminars of health topics related to aging in African Americans with light stretching and low intensity activites
Eligibility Criteria
You may qualify if:
- self- identify as African American
- years and older
- willing to accept randomization
- willing to attend group sessions
- lacking plans to move during the study period
- free of conditions that would make regular exercise unsafe (e.g. uncontrolled asthma, severe sickle cell disease, etc.)
- not engaged in regular physical activity
- Short Physical Performance Battery score \>/= 4
- physically capable of exercise,
You may not qualify if:
- cognitive impairment that would interfere with participating in group interactions
- unwilling to give written informed consent
- inability to attend group sessions
- conditions that prevent regular exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert L Newton, Jr., PhD
Pennington Biomedical Research Center
- PRINCIPAL INVESTIGATOR
Owen L Carmichael, PhD
Pennington Biomedical Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 26, 2019
Study Start
August 9, 2019
Primary Completion
November 1, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available after data analysis has occurred.
For all study data, Pennington Biomedical has a well-structured internal process for data sharing and transfer. The Office of Legal and Regulatory Compliance is responsible for all data agreements which includes data subject to the protection under HIPAA. As part of the Louisiana State University System, Pennington Biomedical ensures that data agreements are in place in the following circumstances: business associate agreements when the transfer of data contains all identifiers, data use agreements when the transfer of data contains those identifiers that constitute a limited data set and a data transfer agreement in instances where data is de-identified, but still may be subject of protection in order to protect intellectual property rights. Transmission of data to ensure proper safeguards are in place on the data in motion and data at reset are carried out with assistance of the Research Computing Group or the Office of Computing Services.