Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Program for African American Cognition & Exercise (PAACE)

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: NCT03474302
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
BrightFocus Foundation
Information provided by (Responsible Party):
Pennington Biomedical Research Center

Brief Summary:
The study is designed to develop and evaluate a physical activity promotion program among elderly African Americans with a long-term goal of reducing risk of Alzheimer's disease. The motivation for this study is that previous exercise interventions have improved cognitive function in older adults with and without cognitive impairments, but these studies were largely conducted without substantial African American representation. Due to genetic and environmental differences between African American and other populations, it is unclear whether positive findings from previous interventions will translate to African American individuals. We hypothesize that a community-based physical activity intervention will a) be tailored to African American adults, b) increase daily amounts of physical activity, and c) improve cognitive function in sedentary older African American adults.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Physical Activity Other: Successful Aging Not Applicable

Detailed Description:

We will randomize 56 older African American adults into 1) a physical activity intervention specifically tailored to older African American or 2) a successful aging group. The 12-week physical activity intervention will consist of group based exercise sessions at a community facility and the successful aging groups will occur at Pennington Biomedical. Cognitive functioning and blood markers of circulating neurotrophic factors will be assessed to determine the brain effects of physical activity in this understudied population.

Specific Aim 1: To tailor a physical activity promotion intervention to community-dwelling African American elderly adults. We will use focus groups to gather information needed to tailor a physical activity program to elderly African Americans.

Specific Aim 2: To determine if a physical activity promotion intervention in African American adults is effective in modifying physical activity and biological markers.

Specific Aim 3: To determine if a physical activity promotion intervention in African American adults benefits cognition and brain health. Change over the course of the intervention will be assessed in key AD related cognitive domains (memory, executive function, and processing speed).

Collecting this data sets the stage for the definitive study of exercise benefits on measures of amyloid, tau, inflammation, brain metabolism, and other AD-relevant pathways in elderly African Americans, which could in turn increase understanding of neurobiological mechanisms and optimal physical activity recommendations for elderly African Americans.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The randomized controlled trial will assign insufficiently active African American adults aged 65-85 to an intervention or successful aging control group
Masking: Single (Outcomes Assessor)
Masking Description: Assessors will not know the group randomization of the participants.
Primary Purpose: Prevention
Official Title: Program for African American Cognition & Exercise
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : April 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Activity
The intervention will be a 12-week community-based physical activity promotion program
Behavioral: Physical Activity
Aerobic, strength training, balance, flexibility

Active Comparator: Successful Aging
Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks
Other: Successful Aging
Healthy aging education




Primary Outcome Measures :
  1. Mean change in steps [ Time Frame: 7-day period at both baseline and 12 weeks ]
    Measured via Actigraph WGT3X+ accelerometer between groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. 65 - 85 years of age
  2. African American
  3. sedentary or insufficiently active
  4. not cognitively impaired
  5. physically capable of exercise
  6. willing to accept randomization
  7. willing to attend group sessions
  8. willing to live in the study area for the next 6 months
  9. willing to allow researchers to use data for research purposes after study participation is completed
  10. free of conditions that would make regular exercise unsafe as deemed by the medical investigator

Exclusion Criteria:

  1. unable or unwilling to give informed consent or accept randomization in either study group
  2. are cognitively impaired (MMSE score of ≤ 26)
  3. are unable to complete physical activity requirements (SPPB ≤ 3, complete 2 minute walk without sitting or resting against a surface)
  4. are too active (steps per day > 50th percentile for age and gender)
  5. have uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
  6. gave had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  7. have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months
  8. are undergoing physical therapy or cardiopulmonary rehabilitation
  9. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
  10. have another member of the household that is a participant in PAACE
  11. have plans to relocate out of the study area within the next 6 months
  12. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
  13. have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol

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): NCT03474302


Contacts
Layout table for location contacts
Contact: Alison Carvile 225-763-3000 recruiters@pbrc.edu
Contact: Callie Hebert 225-763-2632 callie.hebert@pbrc.edu

Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Callie Hebert    225-763-2632    callie.hebert@pbrc.edu   
Principal Investigator: Robert L. Newton, Jr., PhD         
Sponsors and Collaborators
Pennington Biomedical Research Center
BrightFocus Foundation
Investigators
Layout table for investigator information
Principal Investigator: Robert Newton, PhD Pennington Biomedical Research Center

Layout table for additonal information
Responsible Party: Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03474302     History of Changes
Other Study ID Numbers: 2017-022
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pennington Biomedical Research Center:
African American
Aging
Physical activity
Cognition