Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)

Last updated: March 12, 2025
Sponsor: Pennington Biomedical Research Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mental Disability

Memory Loss

Mild Cognitive Impairment

Treatment

Physical activity program

Successful Aging

Clinical Study ID

NCT04956549
PBRC 2020-013
R01AG067765-01
  • Ages > 60
  • All Genders

Study Summary

The RAATE-MCI 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. RAATE-MCI is a 52-week randomized controlled trial. 144 African American adults aged 60 and older will be recruited.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. are African American (self-identify)

  2. are 60 and older

  3. are physically capable of exercise

  4. are willing to accept randomization

  5. are willing to attend group sessions

  6. plan to live in the study area over the next 13 months and capable of traveling todesignated study facility for clinic visits and intervention sessions for the nextyear

  7. are free of conditions (e.g. uncontrolled asthma, severe sickle cell disease, etc.)that would make regular exercise unsafe as deemed by the medical investigator

  8. have not engaged in regular physical activity

  9. have a Short Physical Performance Battery ≥4

  10. physically capable of exercise

  11. are unable to utilize devices and/or applications as required for studyparticipation

  12. willing to attend group sessions

  13. willing to allow researchers to use data for research purposes after studyparticipation is completed

  14. meet criteria for MCI as defined by the NIA-AA research framework a. cognitiveperformance below normal range (score < 1.5 SDs below the mean on NIH Toolbox scoresfor their age and sex on at least one of the subtests)

Exclusion

Exclusion Criteria:

  1. have cognitive impairment that would interfere with participating in a groupdiscussion a. cognitive performance in the demented range (score < 3 SDs below the mean on NIHToolbox scores for their age and sex on at least one of the subtests)

  2. meet criteria for dementia

  3. are unwilling to give written informed consent or accept randomization in eitherstudy group

  4. are too active (as defined by ≥10 min bouts of MVPA as measured by Actigraph) if:

  5. Sum of MVPA bouts for the 7 day wear period ≥40 mins

  6. Or ≤40 mins of MVPA 10min bouts AND ≥3 days of bouts

  7. have uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolicblood pressure > 90 mmHg).

  8. have had a myocardial infarction, major heart surgery (i.e., valve replacement orbypass surgery), stroke, deep vein thrombosis, pulmonary embolus, hip fracture, hipor knee replacement, or spinal surgery in the past 6 months

  9. are undergoing cardiopulmonary rehabilitation

  10. have uncontrolled diabetes that in the judgment of the MI may interfere with studyparticipation

  11. have clinically diagnosed osteoporosis that in the judgment of the MI may interferewith study participation

  12. are currently enrolled in another randomized trial involving lifestyle orpharmaceutical interventions

  13. have another member of the household that is a participant in RAATE or RAATE MCI

  14. refuse to participate in the study without disclosure of their amyloid PET scanresults

  15. refuse to allow anonymized versions of their study data for research after thisstudy is completed.

  16. have other medical, psychiatric, or behavioral factors that in the judgment of thePrincipal or Medical Investigator may interfere with study participation or theability to follow the intervention protocol

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Physical activity program
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
March 31, 2027

Study Description

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. 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. Therefore, our study is focused on physical activity promotion, a potent approach to modifying multiple neurobiological pathways implicated in Alzheimer's Disease. RAATE-MCI is a 52-week randomized controlled trial that will assign insufficiently active African American adults aged 60 and older to one of two groups: a physical activity intervention or a successful aging (active control) group. Outcome measures will be collected at baseline, 24-,and 52-weeks. 144 older African American adults will be recruited.

Intervention will consist of one of two groups: a 150 minutes of physical activity (PA) per week or successful aging (SA) group. All physical activity and successful aging group sessions will be conducted at Pennington Biomedical or at local community facilities that include branches of the YMCA and community centers.

Connect with a study center

  • Pennington Biomedical Research

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.