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

Recruiting now · Not applicable

Conditions studied: Dementia of Alzheimer Type

In brief

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.

Key facts

Study ID

NCT04956549

Run by

Pennington Biomedical Research Center

People needed

144

Starts

2021-06-01

Expected to finish

2027-03-31

Last updated by the study team

2025-03-17

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• are African American (self-identify)
• are 60 and older
• 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
• 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)

You may not qualify if…

• have cognitive impairment that would interfere with participating in a group discussion
• a. 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
• 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

Where it is running

• Pennington Biomedical Research — Baton Rouge, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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