Clinical trial NCT03890861: Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
Official title: Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia, Alzheimer Type
Keywords: African American
Aging
Physical activity
Cognition
Prevention
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-03-26
Enrollment: 125
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

1. self- identify as African American
2. 60 years and older
3. willing to accept randomization
4. willing to attend group sessions
5. lacking plans to move during the study period
6. free of conditions that would make regular exercise unsafe (e.g. uncontrolled asthma, severe sickle cell disease, etc.)
7. not engaged in regular physical activity
8. Short Physical Performance Battery score \>/= 4
9. physically capable of exercise,

Exclusion Criteria:

1. cognitive impairment that would interfere with participating in group interactions
2. unwilling to give written informed consent
3. inability to attend group sessions
4. conditions that prevent regular exercise
5. conditions that the medical or principal investigator determine to warrant exclusion

Primary outcomes:
measure: Change in episodic memory
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in executive function
timeFrame: Baseline, 24 weeks, 52 weeks
Secondary outcomes:
measure: Change in cognitive status
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in glucose
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in time spent in physical activity
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in cardiorespiratory fitness
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in physical function-NIH Toolbox
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in telomere length
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in weight
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in brain structure
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Changes in brain function
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in lipoproteins
timeFrame: Baseline, 24 weeks, 52 weeks
measure: APOE genotype
timeFrame: Baseline
measure: Change in physical activity
timeFrame: Continuously for 52 weeks
measure: Change in blood pressure
timeFrame: Blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
measure: Change in mood
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in height
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change in physical function-SPPB
timeFrame: Baseline, 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Robert L Newton, Jr., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research Center
name: Owen L Carmichael, PhD
role: PRINCIPAL_INVESTIGATOR
References: