Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)" (RAATE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03890861|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : June 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dementia, Alzheimer Type||Behavioral: Physical activity Behavioral: Successful Aging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"|
|Actual Study Start Date :||August 9, 2019|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||November 30, 2023|
Experimental: Physical activity intervention
The intervention 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. Participants will engage in 2 days per week of supervised activity at community facilities. These participants will be requested to engage in an additional 30 minutes of moderate to vigorous aerobic physical activity two days per week at home.
Behavioral: Physical activity
Promotion of physical activity to the current federal physical activity guidelines.
Active Comparator: Active control
The active control group will be based on a low-intensity activity program and a healthy aging educational component. 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.
Behavioral: Successful Aging
Seminars of health topics related to aging in African Americans with light stretching and low intensity activites
- Change in episodic memory [ 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.
- Change in executive function [ Time Frame: Baseline, 24 weeks, 52 weeks ]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.
- Change in cognitive status [ Time Frame: Baseline, 24 weeks, 52 weeks ]The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.
- Change in glucose [ Time Frame: Baseline, 24 weeks, 52 weeks ]Fasting levels of glucose will be assessed using standard assays.
- Change in time spent in physical activity [ 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.
- Change in cardiorespiratory fitness [ 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.
- Change in physical function-NIH Toolbox [ 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.
- Change in telomere length [ 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
- Change in weight [ Time Frame: Baseline, 24 weeks, 52 weeks ]Weight will be measured using a standard stadiometer. Measurements will be taken to the nearest cm.
- Change in brain structure [ 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.
- Changes in brain function [ 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.
- Change in lipoproteins [ Time Frame: Baseline, 24 weeks, 52 weeks ]Fasting levels of lipids will be assessed using standard assays.
- APOE genotype [ Time Frame: Baseline ]APOE genotype will be assessed using standard assays.
- Change in physical activity [ Time Frame: Continuously for 52 weeks ]The Fitbit Charge 2 will be worn by participants in both groups.
- Change in blood pressure [ Time Frame: Blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff. ]Blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.
- Change in mood [ Time Frame: Baseline, 24 weeks, 52 weeks ]The Geriatric Depression Scale will be used to measure depressive symptoms.
- Change in height [ Time Frame: Baseline, 24 weeks, 52 weeks ]Height will be assessed using a standard stadiometer.
- Change in physical function-SPPB [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890861
|Contact: Melissa Harris, PhD||225763091||Melissa.Harris@pbrc.edu|
|United States, Louisiana|
|Pennington Biomedical Research Center||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Contact: Melissa Harris, MA 225-763-3091 Melissa.Harris@pbrc.edu|
|Contact: Jessica St. Romain, MA 2257632921 Jessica.Stromain@pbrc.edu|
|Principal Investigator: Robert L Newton, Jr., PhD|
|Principal Investigator: Owen Carmichael, PhD|
|Principal Investigator:||Robert L Newton, Jr., PhD||Pennington Biomedical Research Center|
|Principal Investigator:||Owen L Carmichael, PhD||Pennington Biomedical Research Center|