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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890861
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume.)
First Posted : March 26, 2019
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Robert L. Newton, Jr., Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE August 9, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
Official Title  ICMJE Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
Brief Summary The RAATE 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. There are three main objectives of the protocol: 1) to determine if a physical activity intervention tailored to older African American adults is effective in modifying cognitive function associated with Alzheimer's Disease, 2) to determine if a physical activity intervention tailored to older African American adults is effective in modifying brain function and structure associated with Alzheimer's Disease, and 3) to determine if a physical activity promotion intervention tailored to African American adults is effective at enhancing physiological parameters. The primary endpoints for the study are episodic memory and executive functioning. The secondary outcomes include anthropometry, blood pressure, brain activation, cerebral blood flow, volume of whole brain and white matter hyperintensities, cardiorespiratory fitness, objectively measured physical activity, circulating hormones, and telomere length.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Dementia, Alzheimer Type
Intervention  ICMJE
  • Behavioral: Physical activity
    Promotion of physical activity to the current federal physical activity guidelines.
  • Behavioral: Successful Aging
    Seminars of health topics related to aging in African Americans with light stretching and low intensity activites
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Physical activity
  • 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.
    Intervention: Behavioral: Successful Aging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2023
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. self- identify as African American
  2. 65 - 85 years of age
  3. willing to accept randomization
  4. willing to attend group sessions
  5. lacking plans to move during the study period
  6. free of conditions that would make regular exercise unsafe (e.g. uncontrolled asthma, severe sickle cell disease, etc.)
  7. not engaged in regular physical activity
  8. score >/=27 on the Mini-Mental State Examination, and 9) a Short Physical Performance Battery score >/= 4
  9. physically capable of exercise,

Exclusion Criteria:

  1. cognitive impairment that would interfere with participating in group interactions
  2. unwilling to give written informed consent
  3. inability to attend group sessions
  4. conditions that prevent regular exercise
  5. conditions that the medical or principal investigator determine to warrant exclusion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03890861
Other Study ID Numbers  ICMJE PBRC2019-002
R01AG062200-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: For all study data, Pennington Biomedical has a well-structured internal process for data sharing and transfer. The Office of Legal and Regulatory Compliance is responsible for all data agreements which includes data subject to the protection under HIPAA. As part of the Louisiana State University System, Pennington Biomedical ensures that data agreements are in place in the following circumstances: business associate agreements when the transfer of data contains all identifiers, data use agreements when the transfer of data contains those identifiers that constitute a limited data set and a data transfer agreement in instances where data is de-identified, but still may be subject of protection in order to protect intellectual property rights. Transmission of data to ensure proper safeguards are in place on the data in motion and data at reset are carried out with assistance of the Research Computing Group or the Office of Computing Services.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data will be available after data analysis has occurred.
Responsible Party Robert L. Newton, Jr., Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Robert L Newton, Jr., PhD Pennington Biomedical Research Center
Principal Investigator: Owen L Carmichael, PhD Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP