ENhancing Independence Using Group-Based Community Interventions for Healthy AGing Elders: The ENGAGE for Brain Health Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Measuring the safety of a 6 month PA or HE intervention in a community setting in older adults with MCR
研究概览
简要总结
Age-related cognitive decline has a profound impact on the daily functioning of older adults, their families and healthcare systems. Despite its significant personal, societal and economic impact, no pharmacologic therapies presently exist to mitigate age-related cognitive decline. As the population of older adults continues to rapidly increase, the implementation of effective and scalable low-cost interventions that may maintain the cognitive independence of broad populations of older persons are now of urgent public health priority.
详细描述
ENGAGE-B is a single blind, parallel-group, community-based randomized controlled pilot study. The overall objective of the study is to build on our recently completed ENGAGE pilot study and further examine and characterize the feasibility and effectiveness of translating the LIFE study physical activity intervention (PA) into a real-world community-based senior center setting. ENGAGE-B will target the recruitment of older adults with subjective memory complaints and slow gait (motoric cognitive risk syndrome (MCR)). Participants with MCR will be randomized to a 24-week PA intervention (n = 20) or to a healthy aging education control intervention (HE) (n = 20). ENGAGE-B will also test a highly practical and scalable innovation for the delivery of exercise programming for at-risk older adults in the community setting. An existing community-based senior center employee ("Community Health Promoter"), without a formal background in exercise physiology, will be trained by the study investigators to deliver the PA intervention among older adults with MCR. The primary feasibility outcomes will be assessed by quantifying intervention adherence and the occurrence of adverse events across the PA and HE intervention arms. Secondary and exploratory outcomes will include the comparative evaluation of specific domains of cognitive performance (executive function, global cognition, working memory, computerized cognitive testing and complex walking tasks), non-invasive functional near-infrared spectroscopy (fNIRS) derived measures of prefrontal brain activation, mobility, accelerometry-derived estimates of physical activity, depression, quality of life and costs associated with delivering the respective interventions. Results from this proposed pilot study are intended as the basis for a larger and more definitive pragmatic trial in older adults. If successful this pilot work will serve as an exciting preliminary model to potentially target and mitigate the loss of cognitive independence across a variety of community-based locations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No one is blinded during this study.
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Men and Women age 60-89 years, community-dwelling, ambulatory
- •Presence of MCR syndrome
- •Sedentary (reporting ≤ 20 min/week of regularly structured physical activity in the past month)
- •Written permission from PCP for study participation
- •Willingness to be randomized and participate for 24 weeks
排除标准
- •• Acute or terminal illness
- •Modified Mini-Mental State Examination Score <80(<76 if African American)*
- •Myocardial Infarction in the previous 6 months
- •Symptomatic coronary artery disease
- •Upper or lower extremity fracture in the previous 6 months
- •Resting blood pressure >180/100 mmHg
- •Unable to communicate due to severe hearing loss or speech disorder
- •Severe visual impairment that may preclude participation in the study assessments or interventions
- •Non-English speaking
研究组 & 干预措施
Physical Activity Intervention (PA)
The PA intervention will consist of a twice per week group-based moderate-intensity program that includes aerobic, strength, flexibility, and balance training.
干预措施: Physical Activity (PA) Intervention (Other)
Health Education Intervention (HE)
The HE intervention will consist of bimonthly lifestyle counseling workshops in a group setting. Participants will receive information on a variety of topics including relevance to older adults, including nutrition, understanding the health care system, dietary guidelines for older adults, safe travel, age-appropriate preventive services, information on resources, etc.
干预措施: Healthy Aging Education (HE) Intervention (Other)
结局指标
主要结局
Measuring the safety of a 6 month PA or HE intervention in a community setting in older adults with MCR
时间窗: 6 Months
Safety will be measured by the number of adverse events and serious adverse events. The investigators will compare the rates of adverse events and serious adverse events between the physical activity and healthy aging education intervention randomized arms.
Measuring the success (feasibility) of integrating clinical exercise programs into real-world community-based settings.
时间窗: 6 Months
Feasibility will be measured by adherence to PA by percent attendance. Successful adherence will be defined by an attendance rate of \>60%.
次要结局
- Grip Strength Test(6 Months)
- Complex Walking Tasks (CWT's)(6 Months)
- fNIRS (Functional Near-Infrared Spectroscopy) assessment and submaximal cycle ergometry(6 Months)
- 6-Minute Walk Test (6MWT)(6 Months)
- Accelerometry(6 Months)
- Quality of Well Being(6 Months)
- Falls Efficacy Scale-International(6 Months)
- Fall History(6 Months)