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Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)" (RAATE)

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ClinicalTrials.gov Identifier: NCT03890861
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Robert L. Newton, Jr., Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Dementia, Alzheimer Type Behavioral: Physical activity Behavioral: Successful Aging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE)"
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : November 30, 2023


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in cognitive status [ Time Frame: Baseline, 24 weeks, 52 weeks ]
    The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.

  2. Change in glucose [ Time Frame: Baseline, 24 weeks, 52 weeks ]
    Fasting levels of glucose will be assessed using standard assays.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. Change in lipoproteins [ Time Frame: Baseline, 24 weeks, 52 weeks ]
    Fasting levels of lipids will be assessed using standard assays.

  11. APOE genotype [ Time Frame: Baseline ]
    APOE genotype will be assessed using standard assays.

  12. Change in physical activity [ Time Frame: Continuously for 52 weeks ]
    The Fitbit Charge 2 will be worn by participants in both groups.

  13. 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.

  14. Change in mood [ Time Frame: Baseline, 24 weeks, 52 weeks ]
    The Geriatric Depression Scale will be used to measure depressive symptoms.

  15. Change in height [ Time Frame: Baseline, 24 weeks, 52 weeks ]
    Height will be assessed using a standard stadiometer.

  16. 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.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Harris, PhD 225763091 Melissa.Harris@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Not yet 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         
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Robert L Newton, Jr., PhD Pennington Biomedical Research Center
Principal Investigator: Owen L Carmichael, PhD Pennington Biomedical Research Center

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Responsible Party: Robert L. Newton, Jr., Associate Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03890861     History of Changes
Other Study ID Numbers: PBRC2019-002
R01AG062200-01 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available after data analysis has occurred.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert L. Newton, Jr., Pennington Biomedical Research Center:
African American
Aging
Physical activity
Cognition
Prevention

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders