Pennington Biomedical Research
Baton Rouge, Louisiana, 70808, United States
Location status: Recruiting
Location contact
Callie Hebert, MS
CONTACT
Jenny Ricks, MA
CONTACT
NCT Number: NCT04956549
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
Location status: Recruiting
Callie Hebert, MS
CONTACT
Jenny Ricks, MA
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
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.
Other names: active control
Time frame: Baseline, 24 weeks, 52 weeks
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
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
The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.
Time frame: Baseline, 24 weeks, 52 weeks
Fasting levels of glucose will be assessed using standard assays.
Time frame: Baseline, 24 weeks, 52 weeks
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
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
Physical function will be assessed using the NIH-TB Motor assessment, which assesses dexterity, balance, locomotion, grip strength, and strength.
Time frame: Baseline, 24 weeks, 52 weeks
DNA will be extracted from the blood draw and amplified using real-time quantitative polymerase chain reaction (qPCR) to determine average relative telomere length represented by the telomere repeat copy number to single gene copy number (T/S) ratio in triplicate as previously described
Time frame: Baseline, 24 weeks, 52 weeks
Weight will be measured using a standard stadiometer. Measurements will be taken to the nearest cm.
Time frame: Baseline, 24 weeks, 52 weeks
Volumes of the cranial vault, brain tissue, gray matter, white matter, and cerebrospinal fluid, which will be provided as the primary brain structural outcome measures of interest from MRI.
Time frame: Baseline, 24 weeks, 52 weeks
Pre-selected inhibitory control ROIs (ACC for the Stroop; DLPFC, thalamus, superior frontal, inferior frontal, fusiform, and middle frontal gyri; and ACC and middle frontal gyri for the ANT) are of primary interest.
Time frame: Baseline, 24 weeks, 52 weeks
Fasting levels of lipids will be assessed using standard assays.
Time frame: Baseline
APOE genotype will be assessed using standard assays.
Time frame: Continuously for 52 weeks
The Fitbit Charge 2 will be worn by participants in both groups.
Time frame: SV, 26 weeks, 52 weeks
Systolic blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
Time frame: SV, 26 weeks, 52 weeks
Diastolic blood pressure (both systolic and diastolic) will be measured using the Omron, Model BP710 automatic blood pressure cuff.
Time frame: Baseline, 24 weeks, 52 weeks
The Geriatric Depression Scale will be used to measure depressive symptoms.
Time frame: Baseline, 24 weeks, 52 weeks
Height will be assessed using a standard stadiometer.
Time frame: Baseline, 24 weeks, 52 weeks
Physical function will be assessed using the the Short Physical Performance Battery (SPPB), which is a brief performance battery based on timed short distance walk, repeated chair stands and balance test.
Contact information is provided by the study sponsor or research team.
Pennington Biomedical Research Center
Other
Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort
Acronym: RAATE-MCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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