Women's Health Initiative Strong and Healthy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49,331
- 主要终点
- Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
研究概览
简要总结
The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to ~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise & Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.
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)
入排标准
- 年龄范围
- 66 Years 至 99 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently enrolled in the Women's Health Initiative (WHI) Extension Study
- •Known to be alive
- •Cardiovascular outcomes will be available (enrolled in the WHI Medical Records Cohort or linked to Medicare Data)
排除标准
- •Inability to walk
- •Residing in a nursing home
研究组 & 干预措施
Usual Activity Control
Usual activity
Physical Activity Intervention
The Physical Activity Intervention Group will receive guidance on being physically active, including aerobics, flexibility, balance, strength, and decreased sedentary time. The primary resource is the National Institute of Aging Go4Life exercise and physical activity materials. The materials are based on the United States national guidelines for physical activity for older adults
干预措施: Physical Activity (Behavioral)
结局指标
主要结局
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
时间窗: 9 years
Adjudicated events
Non-Cardiovascular Disease Mortality
时间窗: 9 years
Safety; adjudicated event
Hip Fracture
时间窗: 9 years
Safety; adjudicated event
Clinical (non-hip) Fracture
时间窗: 9 years
Safety
Falls
时间窗: 9 years
Safety; self-report
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
时间窗: 9 years
Adjudicated events
Physical Function (Physical Function Score from self-report, RAND-36)
时间窗: 9 years
Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning.
Non-Cardiovascular Disease Mortality
时间窗: 9 years
Safety; adjudicated event
Hip Fracture
时间窗: 9 years
Safety; adjudicated event
Clinical (non-hip) Fracture
时间窗: 9 years
Safety
Falls
时间窗: 9 years
Safety; self-report
次要结局
- Mobility and Independence (Physical Function Score from self-report)(9 years)
- Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)(9 years)
- Short Physical Performance Battery (SPPB)(4 years)
- Sleep Disturbance(4 years)
- Depressive Symptoms(4 years)
- Venous Thromboembolic Event(9 years)
- Peripheral Artery Disease(9 years)
- Venous Thromboembolic Event(9 years)
- Peripheral Artery Disease(9 years)
- Mobility and Independence (Physical Function Score from self-report)(9 years)
- Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)(9 years)
- Short Physical Performance Battery (SPPB)(4 years)
- Sleep Disturbance(4 years)
- Depressive Symptoms(4 years)