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

  • STATUS
    Recruiting
  • End date
    May 31, 2026
  • participants needed
    144
  • sponsor
    Pennington Biomedical Research Center
Updated on 13 August 2021

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 65-85 will be recruited.

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 65 - 85 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.

Details
Condition Dementia of Alzheimer Type
Treatment Physical activity program, Successful Aging
Clinical Study IdentifierNCT04956549
SponsorPennington Biomedical Research Center
Last Modified on13 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

are African American (self-identify)
are 65 - 85 years of age
are physically capable of exercise
are willing to accept randomization
are willing to attend group sessions
plan to live in the study area over the next 13 months and capable of traveling to designated study facility for clinic visits and intervention sessions for the next year
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
have not engaged in regular physical activity
have a Short Physical Performance Battery 4
physically capable of exercise
are unable to utilize devices and/or applications as required for study participation
willing to attend group sessions
are willing to have a study partner
willing to allow researchers to use data for research purposes after study participation is completed
meet criteria for MCI as defined by the NIA-AA research framework a. cognitive performance below normal range (score < 1.5 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests)

Exclusion Criteria

have cognitive impairment that would interfere with participating in a group discussion
cognitive performance in the demented range (score < 3 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests)
meet criteria for dementia
are unwilling to give written informed consent or accept randomization in either study group
are too active (as defined by 10 min bouts of MVPA as measured by Actigraph) if
Sum of MVPA bouts for the 7 day wear period 40 mins
Or 40 mins of MVPA 10min bouts AND 3 days of bouts
have uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg)
have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis, pulmonary embolus, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
are undergoing cardiopulmonary rehabilitation
have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation
are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
have another member of the household that is a participant in RAATE or RAATE MCI
do not have a supportive partner for participation
have a contraindication to MRI
have a contraindication to PET: Estimated radiation exposure over the past 12 months greater than 5000 mRem, per PBRC Radiation Safety Committee screening form
refuse to participate in the study without disclosure of their amyloid PET scan results
refuse to allow anonymized versions of their study data for research after this study is completed
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
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