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

Official title

Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort

Overview

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.

Detailed 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.

Interventions

• Behavioral Physical activity program
  Supervised group sessions will be held twice per week for approximately 52 weeks. Each physical activity session will last slightly approximately 80 minutes and will consist of aerobic, strength, flexibility, and balance training. The 80 minutes of activity consists of a 5 minute warm-up, 45 minutes of aerobic training, 15 minutes of strength training, 10 minutes of balance training, and a 5 minute cool-down. The physical activity group will target 150 minutes of moderate to vigorous aerobic phy
• Behavioral Successful Aging
  The successful aging group will be based on a low-intensity activity program and a healthy aging educational component. Sessions will be approximately 60 minutes in duration and will occur once per week for the first 6 months and then every other week for the remainder 6 months of the study. The physical activities will include stretching, balance training, flexibility, relaxation, and practicing activities of daily living. The successful aging education component will cover topics including avo

Primary outcome measures

• Change in executive function [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in episodic memory [Time frame: Baseline, 24 weeks, 52 weeks]

Secondary outcome measures (12)

• Change in cognitive status [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in glucose [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in time spent in physical activity [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in cardiorespiratory fitness [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in physical function-NIH Toolbox [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in telomere length [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in weight [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in brain structure [Time frame: Baseline, 24 weeks, 52 weeks]
• Changes in brain function [Time frame: Baseline, 24 weeks, 52 weeks]
• Change in lipoproteins [Time frame: Baseline, 24 weeks, 52 weeks]
• APOE genotype [Time frame: Baseline]
• Change in physical activity [Time frame: Continuously for 52 weeks]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Pennington Biomedical Research — Baton Rouge

Identifiers

NCT: NCT04956549 · PBRC 2020-013 · R01AG067765-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗