Program for African American Cognition & Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in steps.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will not know the group randomization of the participants.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 - 85 years of age
- •African American
- •sedentary or insufficiently active
- •not cognitively impaired
- •physically capable of exercise
- •willing to accept randomization
- •willing to attend group sessions
- •willing to live in the study area for the next 6 months
- •willing to allow researchers to use data for research purposes after study participation is completed
- •free of conditions that would make regular exercise unsafe as deemed by the medical investigator
排除标准
- •unable or unwilling to give informed consent or accept randomization in either study group
- •are cognitively impaired (MMSE score of ≤ 26)
- •are unable to complete physical activity requirements (SPPB ≤ 3, complete 2 minute walk without sitting or resting against a surface)
- •are too active (steps per day > 50th percentile for age and gender)
- •have uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
- •gave had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- •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
- •are undergoing physical therapy or cardiopulmonary rehabilitation
- •are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
- •have another member of the household that is a participant in PAACE
- •have plans to relocate out of the study area within the next 6 months
- •have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
- •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
结局指标
主要结局
Change in steps.
时间窗: 7-day period
Steps will be measured by the abtigraph WGT3X+ accelerometer.
次要结局
- Change in health care utilization.(Week 0 and Week 12)
- Change in depressive symptoms.(Week 0 and Week 12)
- Change in dementia screening.(Week 0 and Week 12)
- Change in cognition.(Week 0 and Week 12)
- Change in quality of life.(Week 0 and Week 12)
- Change in resilience.(Week 0 and Week 12)
研究者
Robert L. Newton, Jr.
Associate Professor
Pennington Biomedical Research Center