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
|Condition or disease||Intervention/treatment||Phase|
|Aging||Behavioral: Physical Activity Other: Successful Aging||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|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.|
|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|
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
- Mean change in steps [ Time Frame: 7-day period at both baseline and 12 weeks ]Measured via Actigraph WGT3X+ accelerometer between groups
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
|Contact: Alison Carvilefirstname.lastname@example.org|
|Contact: Callie Hebertemail@example.com|
|United States, Louisiana|
|Pennington Biomedical Research Center||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Contact: Callie Hebert 225-763-2632 firstname.lastname@example.org|
|Principal Investigator: Robert L. Newton, Jr., PhD|
|Principal Investigator:||Robert Newton, PhD||Pennington Biomedical Research Center|