Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"

NCT ID: NCT03890861

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2026-11-30

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.

Conditions

Dementia, Alzheimer Type

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Physical activity intervention

The 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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Promotion of physical activity to the current federal physical activity guidelines.

Active control

The 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.

Group Type: ACTIVE_COMPARATOR

Successful Aging

Intervention Type: BEHAVIORAL

Seminars of health topics related to aging in African Americans with light stretching and low intensity activites

Interventions

Physical activity

Promotion of physical activity to the current federal physical activity guidelines.

Intervention Type: BEHAVIORAL

Successful Aging

Seminars of health topics related to aging in African Americans with light stretching and low intensity activites

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Robert L. Newton, Jr.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert L Newton, Jr., PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Owen L Carmichael, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melissa Harris, PhD

Role: CONTACT

Melissa.Harris@pbrc.edu

225763091

Facility Contacts

Melissa Harris, MA

Role: primary

Melissa.Harris@pbrc.edu

2257633091

Jessica St. Romain, MA

Role: backup

Jessica.Stromain@pbrc.edu

2257632921

Robert L Newton, Jr., PhD

Role: backup

Owen Carmichael, PhD

Role: backup

Other Identifiers

R01AG062200-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2019-002

Identifier Type: -

Identifier Source: org_study_id