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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorPennington Biomedical Research Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

self- identify as African American

60 years and older

willing to accept randomization

willing to attend group sessions

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical activity

    Behavioral

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

  • Successful Aging

    Behavioral

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

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Physical activity interventionExperimental treatment 1 intervention
Group B: Active controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 24 weeks, 52 weeks
2

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.

Time frame
Baseline, 24 weeks, 52 weeks

Secondary outcomes

1

Change in cognitive status

The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.

Time frame
Baseline, 24 weeks, 52 weeks
2

Change in glucose

Fasting levels of glucose will be assessed using standard assays.

Time frame
Baseline, 24 weeks, 52 weeks
3

Change in time spent in physical activity

The Actigraph WGT3X+ accelerometer (ActiGraph LLC, Pensacola, FL) will be worn by the participant for a 7-day period. The device provides both the number of steps per day as well as time in sedentary, light, moderate, and vigorous activity in 1-minute epochs (for adults) using the default filter.

Time frame
Baseline, 24 weeks, 52 weeks
4

Change in cardiorespiratory fitness

All participants will perform a standardized graded exercise testing protocol administered on a treadmill. Fitness will be measured in terms of mL oxygen/kg/min.

Time frame
Baseline, 24 weeks, 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator