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

NCT04956549 | Recruiting

• 2 other identifiers: PBRC 2020-013R01AG067765-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia of Alzheimer Type

Outcome Measures

Primary Outcomes (2)

• Change in executive function

  The primary outcome measure will be executive function measured by the NIH-Toolbox Cognitive Battery. 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.

  Baseline, 24 weeks, 52 weeks

• 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.

  Baseline, 24 weeks, 52 weeks

Secondary Outcomes (17)

• Change in cognitive status

  Baseline, 24 weeks, 52 weeks

• Change in glucose

  Baseline, 24 weeks, 52 weeks

• Change in time spent in physical activity

  Baseline, 24 weeks, 52 weeks

• Change in cardiorespiratory fitness

  Baseline, 24 weeks, 52 weeks

• Change in physical function-NIH Toolbox

  Baseline, 24 weeks, 52 weeks

Study Arms (2)

Physical Activity

EXPERIMENTAL

150 minutes of physical activity weekly

Behavioral: Physical activity program

Successful Aging

EXPERIMENTAL

Low intensity activity program and a healthy aging educational component

Behavioral: Successful Aging

Interventions

Physical activity program BEHAVIORAL

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 physical activity and two days of strength training, consistent with the current physical activity recommendations.

Physical Activity

Successful Aging BEHAVIORAL

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 avoiding scams, fall prevention, living wills, and dementia awareness.

Also known as: active control

Successful Aging

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Pennington Biomedical Research

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Study Officials

• Robert L Newton, Jr., PhD

  Pennington Biomedical Research

  PRINCIPAL INVESTIGATOR

• Owen Carmichael, PhD

  Pennington Biomedical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Callie Hebert, MS

CONTACT

225-763-2362; callie.hebert@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: June 1, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after data analysis has occurred.

Locations

US (1)