Clinical trial NCT03474302: Program for African American Cognition & Exercise
Official title: Program for African American Cognition & Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: African American
Aging
Physical activity
Cognition
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: BrightFocus Foundation
First posted: 2018-03-22
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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. Investigators 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.

Detailed description: Investigators 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. Investigators 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.

Eligibility 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

Primary outcomes:
measure: Change in steps.
timeFrame: 7-day period
Secondary outcomes:
measure: Change in dementia screening.
timeFrame: Week 0 and Week 12
measure: Change in cognition.
timeFrame: Week 0 and Week 12
measure: Change in quality of life.
timeFrame: Week 0 and Week 12
measure: Change in health care utilization.
timeFrame: Week 0 and Week 12
measure: Change in depressive symptoms.
timeFrame: Week 0 and Week 12
measure: Change in resilience.
timeFrame: Week 0 and Week 12
Other outcomes:
measure: Tailored physical activity program for elderly African American adults
timeFrame: 1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Robert Newton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gwizdala KL, Brouillete R, Beyl R, Johnson W, Hebert C, Carter L, Harris M, Newton RL Jr, Carmichael OT. Exercise Effects on Cognition in Older African Americans: A Pilot Randomized Trial. Front Aging Neurosci. 2022 Jul 22;14:921978. doi: 10.3389/fnagi.2022.921978. eCollection 2022.
citation: Newton RL Jr, Beyl R, Hebert C, Harris M, Carter L, Gahan W, Carmichael O. A Physical Activity Intervention in Older African Americans: The PAACE Pilot Randomized Controlled Trial. Med Sci Sports Exerc. 2022 Oct 1;54(10):1625-1634. doi: 10.1249/MSS.0000000000002956. Epub 2022 May 7.