Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical activity, Successful Aging.
- Who it may be relevant to
- Registry conditions: Dementia, Alzheimer Type. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Alzheimer's disease is steadily increasing in prevalence, with a devastating public health impact. The prevalence of Alzheimer's Disease is higher in African Americans compared to white Americans, thereby constituting a health disparity. Interventions that prevent Alzheimer's disease or change the course of cognitive decline associated with Alzheimer's disease are needed. Most older adults do not achieve recommended levels of physical activity, and this includes African Americans. Regular physical activity has proven to be a safe and effective means to enhance cognitive function in older adults ranging from cognitively healthy to mildly cognitively impaired. Therefore, our study is focused on physical activity promotion, a potent approach to modifying multiple neurobiological pathways implicated in Alzheimer's Disease. We evaluate exercise benefits among elderly African Americans, who are understudied and in whom the natural course of neurodegeneration, exercise effects on neuroprotection and neurodegeneration, and resulting clinical phenotypes may differ. A large body of existing data suggests that exercise improves cardiovascular and cerebrovascular functioning, and thus has the potential to enhance perivascular clearance of amyloid and reduce chronic brain tissue ischemia, among other beneficial effects. At the same time, chronic exercise has been shown to decrease central levels of inflammatory markers and increase central levels of neurotrophic factors, which in turn promote protection against Alzheimer's Disease neurodegeneration pathways via a variety of mechanisms. While physical activity interventions have been shown to have positive effects on these factors and on resultant cognitive functioning in older adults, nearly all interventions have had a negligible representation of African Americans. Prior data suggests that African Americans enter their elderly years against a backdrop of different lifespan exposures to a variety of factors relevant to neuroprotection and neurodegeneration, including cardiovascular risk, exercise, diet, and education. In addition, prior data suggests that the key genetic risk factor for Alzheimer's Disease (APOE) may have differing consequences for Alzheimer's Disease risk among African Americans, and other genetic differences have the potential to influence the brain benefits of physical activity in this community. We will utilize a randomized clinical trial to addresses these questions. Participants will be randomized into a physical activity promotion intervention or a healthy aging information group for 52 weeks. All participants will be of normal cognitive function. We will assess cognitive function, brain structure and function, circulating hormones, objectively measured physical activity, cardiorespiratory fitness, and telomere length. Our study will take the first step toward understanding whether the hypothesized benefits of exercise for the brain carry over to elderly African Americans.
Interventions
- Behavioral Physical activity
Promotion of physical activity to the current federal physical activity guidelines. - Behavioral Successful Aging
Seminars of health topics related to aging in African Americans with light stretching and low intensity activites
Primary outcome measures
- Change in episodic memory [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in executive function [Time frame: Baseline, 24 weeks, 52 weeks]
Secondary outcome measures (12)
- Change in cognitive status [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in glucose [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in time spent in physical activity [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in cardiorespiratory fitness [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in physical function-NIH Toolbox [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in telomere length [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in weight [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in brain structure [Time frame: Baseline, 24 weeks, 52 weeks]
- Changes in brain function [Time frame: Baseline, 24 weeks, 52 weeks]
- Change in lipoproteins [Time frame: Baseline, 24 weeks, 52 weeks]
- APOE genotype [Time frame: Baseline]
- Change in physical activity [Time frame: Continuously for 52 weeks]
Eligibility criteria
Inclusion criteria
- self- identify as African American
- 60 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,
Exclusion criteria
- 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
- conditions that the medical or principal investigator determine to warrant exclusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Pennington Biomedical Research Center — Baton Rouge
Identifiers
NCT: NCT03890861 · PBRC 2019-002 · R01AG062200-01