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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorPennington Biomedical Research Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

are African American (self-identify)

are 60 and older

are physically capable of exercise

are willing to accept randomization

Disqualifiers

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

meet criteria for dementia

are unwilling to give written informed consent or accept randomization in either study group

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Physical ActivityExperimental treatment 1 intervention
Group B: Successful AgingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 24 weeks, 52 weeks
2

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.

Time frame
Baseline, 24 weeks, 52 weeks

Secondary outcomes

1

Change in cognitive status

The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.

Time frame
Baseline, 24 weeks, 52 weeks
2

Change in glucose

Fasting levels of glucose will be assessed using standard assays.

Time frame
Baseline, 24 weeks, 52 weeks
3

Change in time spent in physical activity

The Actigraph WGT3X+ accelerometer (ActiGraph LLC, Pensacola, FL) will be worn by the participant for a 7-day period. The device provides both the number of steps per day as well as time in sedentary, light, moderate, and vigorous activity in 1-minute epochs (for adults) using the default filter.

Time frame
Baseline, 24 weeks, 52 weeks
4

Change in cardiorespiratory fitness

All participants will perform a standardized graded exercise testing protocol administered on a treadmill. Fitness will be measured in terms of mL oxygen/kg/min.

Time frame
Baseline, 24 weeks, 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator