WHISH-2-Prevent Heart Failure
Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure
研究概览
详细说明
A recently funded large pragmatic PA trial, Women's Health Initiative Strong and Healthy (WHISH) trial based upon two decades of PA intervention experience using enhanced communication and behavioral techniques, has randomized 49,936 elderly women (average age 79) and will evaluate its intervention effect on the risk of atherosclerotic CVD. This translational intervention is aimed at reducing sedentary time and achieving or maintaining aerobic and strength enhancing PA levels currently recommended for cardiovascular benefit. The WHISH-2-Prevent HF, represents the first and largest primary prevention exercise trial ever performed focusing on HF and will examine the intervention effect of PA , on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF.
Aim 1: Test whether older women who are initially free of HF and randomized to a translational PA intervention will reduce the rate of incident HF compared to those not randomized to the translational PA intervention.
H1: Women free of HF randomized to the PA intervention will have reduced rates of incident HF compared to those not randomized.
Aim 2: Test whether older women with and without HF at baseline randomized to a translational PA intervention will reduce the HF burden (number of acute HF hospitalizations and CVD death in those with antecedent HF) compared to those not randomized to the translational PA intervention. H2: Women randomized to the PA intervention will have reduced HF Burden compared to those not randomized
Exploratory Aim 3: Analyze the type, intensity and frequency of physical activity including skeletal muscle strengthening associated with a reduced risk of HF and HF burden in elderly women. H3: Women who have low levels of sedentary behavior by either increasing or maintaining light intensity or moderate intensity physical activity will have reduced rates of HF compared to women who remain sedentary. Those that add skeletal muscle strengthening will have additional benefits.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Rhode Island
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Pawtucket、Rhode Island、美国、02860
- Memorial Hospital of Rhode Island
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- alive, community dwelling,
Exclusion Criteria:
- Dementia, need walking aide, reside in nursing home
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Physical Activity intervention arm
Receive a tailored behavioral interventions for exercise and strength training via multiple channels including frequent mailings, integrated voice response and outreach phone calls, interactive website, and referral to local community exercise resources.
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Physical activity intervention based upon stage of change and social cognitive theory based interventions
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无干预:Control arm
Receive general health mailings
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
hospitalized heart failure
大体时间:within 4 years of randomization
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first acute decompensated hospitalized heart failure event
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within 4 years of randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Heart failure with reduced ejection fraction
大体时间:within 4 years of randomization
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reduced systolic function on echo or other objective imaging
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within 4 years of randomization
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Heart failure with preserved ejection fraction
大体时间:within 4 years of randomization
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normal systolic function on echo or other objective imaging
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within 4 years of randomization
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Recurrent hospitalized heart failure
大体时间:within 4 years of randomization
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number of acute decompensated heart failure events
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within 4 years of randomization
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Cardiovascular disease mortality
大体时间:within 4 years of randomization
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Underlying cause of death was either heart failure or cardiovascular disease
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within 4 years of randomization
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合作者和调查者
合作者
调查人员
- 首席研究员:Charles B Eaton, MD, MS、Memorial Hospital of Rhode Island
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Physical Activity的临床试验
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Weill Medical College of Cornell UniversityWeill Cornell Medical College in Qatar撤销