Physical Activity to Improve CV Health in Older Women: A Pragmatic Trial

这是妇女健康倡议(WHI)强大与健康(WHISH)的竞争性续签申请 审判。美国65岁及以上的人口预计将翻一番，从现在的4900万增加到9500万 2060年，女性人数远远超过男性，特别是在85岁及以上的成年人中。令人信服的证据 支持这样的假设，即体力活动(PA)可以减少心血管疾病(CVD)， 身体功能(PF)和促进老年人心血管健康的其他方面。当它成为一个里程碑的时候， 务实的随机对照试验测试集中化的公共卫生干预措施是否旨在 增加和/或保持PA水平，减少久坐行为将减少主要心血管疾病(MI、中风、心血管疾病 在老年妇女中)。使用随机同意设计来模拟真实世界的编程 实施，Whish在WHI扩展研究中随机选择49,333名合格参与者进行行为测试 干预与2015年5月通常的后续行动。干预组中的被动同意过程 (n=24,663)导致&lt；4%的妇女“选择退出”接受干预材料。Whish提供了一个 针对性、适应性、指导性干预，以2008和2018年国土安全部PA指南为基础，旨在 补充国家老龄研究所(NIA)的Go4Life®活动，使用季节性新闻通讯、手册、 计步器、阻力带、电话和电子邮件激励信息，以及为老年人设计的网站 女人。干预根据参与者来自年度调查的反馈和其他有关活动的意见进行调整 首选项，并针对其当前的PF和PA级别进行定制和定位。初级有效性和安全性 在整个随机队列中使用意向治疗来评估结果(心血管疾病、骨折)。到年底的时候 目前的授权期(2020年2月)，将提供4年的后续行动。根据观察到的CVD 事件发生率、对PA和久坐行为的干预效果，以及与PA行为相关的新的WHI数据 CVD终端，修改后的功率计算表明，我们将只有65%的功率来评估 对心脑血管事件的干预。我们估计，额外4年的后续行动(总共8年)将产生 85%-89%的权力，为主要的Whish假设提供最终的测试。此应用程序建议 将Whish干预和结果跟踪再延长4年，以便试验可以达到 关于巴勒斯坦权力机构干预的好处和风险的明确结论。我们还建议利用数据和 在计划的WHI扩展研究家访中收集生物样品，以实现对关键标记的评估 健康的心血管老化，包括体能、睡眠时间和失眠症状，以及抑郁 症状。将进行试点研究，以探索Whish干预对 已知或推测受PA水平影响的已建立的和新的生物标志物，并指示各种 与心血管疾病老化相关的潜在机制。Whish的结果，无论是积极的、无效的还是不利的， 可能会对PA健康简历老化传播计划的未来产生巨大的翻译影响。

This is a competitive renewal application for the Women’s Health Initiative (WHI) Strong & Healthy (WHISH) trial. America’s 65-and-older population is projected to double in size from 49 million today to 95 million by 2060, with women far outnumbering men, particularly among adults aged 85-and-older. Compelling evidence supports the hypothesis that physical activity (PA) reduces cardiovascular (CV) disease (CVD), preserves physical function (PF) and promotes other aspects of CV health in older adults. WHISH is a landmark, pragmatic randomized controlled trial testing whether a centralized, public health intervention designed to increase and/or maintain PA levels and reduce sedentary behavior will reduce major CVD (MI, stroke, CV death) in older women. Using a randomized consent design to simulate real-world programmatic implementation, WHISH randomized 49,333 eligible participants in the WHI Extension Study to a behavioral intervention versus usual follow-up in May 2015. A passive consent process in the Intervention group (n=24,663) resulted in <4% of women “opting out” of receiving intervention materials. WHISH delivers a targeted, adaptive, instructional intervention, based on 2008 and 2018 DHHS PA guidelines and designed to complement the National Institute on Aging’s (NIA) Go4Life® campaign, using seasonal newsletters, manuals, pedometers, resistance bands, telephone and e-mail motivational messages, and a website designed for older women. The intervention adapts to participant feedback from annual surveys and other input regarding activity preferences and is customized and targeted to their current PF and PA levels. Primary effectiveness and safety outcomes (CVD, fracture) are evaluated using intention-to-treat in the entire randomized cohort. By the end of the current grant period (Feb. 2020), 4 years of follow-up will be available. Based on WHISH observed CVD event rates, intervention effects on PA and sedentary behavior, and new WHI data relating PA behaviors to CVD endpoints, revised power calculations suggest we will have only 65% power to evaluate the impact of the WHISH intervention on CVD events. We estimate that 4 additional years of follow-up (8 years overall) will yield 85-89% power to provide a definitive test of the primary WHISH hypothesis. This application proposes to extend the WHISH intervention and follow-up of outcomes for 4 additional years so that the trial can reach a definitive conclusion on the benefits and risks of the PA intervention. We also propose to leverage data and biospecimen collections in a planned WHI Extension Study home visit to enable evaluation of key markers of healthy CVD aging including physical performance, sleep duration and insomnia symptoms, and depressive symptoms. Pilot studies will be executed to explore long-term effects of the WHISH intervention on changes in established and novel biomarkers known or postulated to be influenced by PA levels and indicative of various underlying mechanisms related to CVD aging. The outcomes of WHISH, whether positive, null, or adverse, could have immense translational impact on the future of PA dissemination programs for healthy CV aging.