ENhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: The ENGAGE Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- This study will assess the feasibility of translating LIFE PA to a real-world community based setting with adequate PA adherence in the community by measuring intervention adherence and retention.
研究概览
简要总结
This study will be conducted to determine the safety and feasibility of translating a physical activity intervention (LIFE Study) into a community setting. Study outcomes include physical performance, safety, and feasibility of conducting the LIFE PA intervention in a community setting.
详细描述
Older adults who lose their mobility experience a poorer quality of life, are less likely to remain independent in the community and have higher rates of chronic disease, falls and mortality. Recent results from the Lifestyle Interventions and Independence for Elders (LIFE) study demonstrated that a structured program of physical activity (PA) reduced the onset of major mobility disability in at-risk older adults by up to 28% over a 2.6 year period. Despite the public health significance of this study, to-date no study has attempted to translate LIFE PA to broader populations of at-risk older adults in community-based settings. To address this knowledge gap, and to aid the design of a larger pragmatic trial of LIFE PA in community-based settings, the investigators conducted the ENhancing independence using Group-based community interventions for healthy AGing in Elders (ENGAGE) pilot study. The investigators examined the safety and feasibility of translating LIFE PA into the existing infrastructure of a community-based senior center. The investigators also explored the preliminary real-world effectiveness of PA on physical performance and several other important health related outcomes for older persons, including cognitive function, quality of life, depressive symptoms and frequency of falling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study assessor will be blinded to the treatment assignment. The study investigators and interventionists will not be blinded.
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females age ≥ 65 and ≤89 years
- •Community dwelling
- •Short Physical Performance Battery ≤ 9
- •No participation in a structured physical activity program within the previous 3 months
- •Willingness to be randomized and participate for 24 weeks
- •Written permission from primary care physician
- •Having obtained his/her informed consent
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 (PA) Intervention
干预措施: Physical Activity Intervention (Other)
Health Education (HE) Intervention
干预措施: Healthy Aging Intervention (Other)
结局指标
主要结局
This study will assess the feasibility of translating LIFE PA to a real-world community based setting with adequate PA adherence in the community by measuring intervention adherence and retention.
时间窗: 6 months
Intervention adherence is measured by percent attendance (number of visits attended/total number of scheduled visits). Successful adherence will be defined by an attendance rate of \>60%. This will be used as an index of feasibility.
This study will assess the safety of translating LIFE PA to a real-world community based setting by monitoring the occurrence of adverse events and serious adverse events.
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.
次要结局
- Isometric Leg strength(6 months)
- Accelerometry(6 months)
- Short physical performance battery (SPPB) test (an additional interim SPPB assessment will be conducted at week 12)(6 months)
- Quality of Well-Being(6 months)
- Depressive symptoms(6 months)
- Nutrition Status(6 months)
- Falls history(6 months)
- Complex Walking Tasks (CWT's)(6 months)
- 400 meter walk(6 months)
- Cognitive performance(6 months)
- Hand-Grip Strength(6 months)