Program for African American Cognition & Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2019-06-30

Brief Summary

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The study is designed to develop and evaluate a physical activity promotion program among elderly African Americans with a long-term goal of reducing risk of Alzheimer's disease. The motivation for this study is that previous exercise interventions have improved cognitive function in older adults with and without cognitive impairments, but these studies were largely conducted without substantial African American representation. Due to genetic and environmental differences between African American and other populations, it is unclear whether positive findings from previous interventions will translate to African American individuals. Investigators hypothesize that a community-based physical activity intervention will a) be tailored to African American adults, b) increase daily amounts of physical activity, and c) improve cognitive function in sedentary older African American adults.

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Detailed Description

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Investigators will randomize 56 older African American adults into 1) a physical activity intervention specifically tailored to older African American or 2) a successful aging group. The 12-week physical activity intervention will consist of group based exercise sessions at a community facility and the successful aging groups will occur at Pennington Biomedical. Cognitive functioning and blood markers of circulating neurotrophic factors will be assessed to determine the brain effects of physical activity in this understudied population.

Specific Aim 1: To tailor a physical activity promotion intervention to community-dwelling African American elderly adults. Investigators will use focus groups to gather information needed to tailor a physical activity program to elderly African Americans.

Specific Aim 2: To determine if a physical activity promotion intervention in African American adults is effective in modifying physical activity and biological markers.

Specific Aim 3: To determine if a physical activity promotion intervention in African American adults benefits cognition and brain health. Change over the course of the intervention will be assessed in key AD related cognitive domains (memory, executive function, and processing speed).

Collecting this data sets the stage for the definitive study of exercise benefits on measures of amyloid, tau, inflammation, brain metabolism, and other AD-relevant pathways in elderly African Americans, which could in turn increase understanding of neurobiological mechanisms and optimal physical activity recommendations for elderly African Americans.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomized controlled trial will assign insufficiently active African American adults aged 65-85 to an intervention or successful aging control group

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Assessors will not know the group randomization of the participants.

Study Groups

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Physical Activity

The intervention will be a 12-week community-based physical activity promotion program

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

Aerobic, strength training, balance, flexibility

Successful Aging

Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks

Group Type ACTIVE_COMPARATOR

Successful Aging

Intervention Type OTHER

Healthy aging education

Interventions

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Physical Activity

Aerobic, strength training, balance, flexibility

Intervention Type BEHAVIORAL

Successful Aging

Healthy aging education

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 65 - 85 years of age
2. African American
3. sedentary or insufficiently active
4. not cognitively impaired
5. physically capable of exercise
6. willing to accept randomization
7. willing to attend group sessions
8. willing to live in the study area for the next 6 months
9. willing to allow researchers to use data for research purposes after study participation is completed
10. free of conditions that would make regular exercise unsafe as deemed by the medical investigator

Exclusion Criteria

1. unable or unwilling to give informed consent or accept randomization in either study group
2. are cognitively impaired (MMSE score of ≤ 26)
3. are unable to complete physical activity requirements (SPPB ≤ 3, complete 2 minute walk without sitting or resting against a surface)
4. are too active (steps per day \> 50th percentile for age and gender)
5. have uncontrolled hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg).
6. gave had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
7. have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months
8. are undergoing physical therapy or cardiopulmonary rehabilitation
9. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
10. have another member of the household that is a participant in PAACE
11. have plans to relocate out of the study area within the next 6 months
12. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
13. have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes