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

体力活动可改善老年女性的心血管健康：一项务实的试验

• 批准号: 10652593
• 负责人: Charles L Kooperberg
• 金额: $ 223.08万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10652593
• 关键词: Address; Adult; Aerobic; Aging; Americas; Ancillary Study; Behavior; Behavior Therapy; Benefits and Risks; Biological Markers; Blood Vessels; Brain natriuretic peptide; Cardiac; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Clinical; Cognitive; Collection; Complement; Consent; Custom; Data; Data Collection; Disease; Educational Intervention; Elderly; Electronic Mail; Ensure; Equilibrium; Ethnic Origin; Evaluation; Event; Evidence based intervention; Exercise; Feedback; Fracture; Funding; Future; Grant; Guidelines; Health; Home visitation; Impairment; Intention; Intervention; Life; Long-Term Effects; Manuals; Measures; Motivation; Myocardial; N-terminal; National Heart, Lung, and Blood Institute; National Institute on Aging; Newsletter; Older Population; Outcome; Participant; Phenotype; Physical Function; Physical Performance; Physical activity; Pilot Projects; Population; Process; Public Health; Race; Randomized; Randomized Controlled Trials; Resistance; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Stroke; Surveys; Symptoms; Telephone; Testing; Troponin T; Woman; Women' s Health; adjudicate; base; cardiovascular disorder risk; cardiovascular health; cohort; depressive symptoms; design; effectiveness outcome; eligible participant; exercise intervention; flexibility; follow-up; group intervention; healthy aging; human very old age (85+); improved; intervention effect; men; myocardial injury; novel marker; older women; pedometer; pilot test; pragmatic trial; preference; preservation; prevent; program dissemination; programs; public health intervention; randomized trial; safety outcomes; sedentary lifestyle; strength training; therapy design; translational impact; web site

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.

这是妇女健康计划（WHI）强大健康（Whish）的竞争更新申请 审判。美国65岁及以下的人口的规模将从今天的4900万增加到9500万人。 2060年，女性远远超过了男性，特别是在85岁及85岁的成年人中。令人信服的证据 支持以下假设，即体育活动（PA）减少心血管（CV）疾病（CVD），保留 身体功能（PF）并促进老年人CV健康的其他方面。 Whish是一个地标， 务实的随机对照试验测试是否旨在进行集中的公共卫生干预措施 提高和/或维持PA水平并降低久坐行为将减少主要CVD（MI，中风，CV 死亡）在老年妇女中。使用随机同意设计模拟现实世界的程序化 实施，在WHI扩展研究中随机49,333名合格参与者 干预措施与通常在2015年5月的随访。干预小组的被动同意程序 （n = 24,663）导致<4％的女性“选择”接受干预材料。 whish提供a 基于2008年和2018年DHHS PA指南的针对性，适应性，教学干预措施，旨在 使用季节性新闻通讯，手册， 计数器，阻力带，电话和电子邮件激励邮件以及专为较旧的网站 女性。干预措施适应了年度调查的反馈和其他有关活动的投入 偏好并定制并针对其当前的PF和PA级别。主要有效性和安全性 在整个随机队列中使用意图对治疗评估结果（CVD，断裂）。到结束 当前的赠款期（2020年2月）将进行4年的随访。基于观察到的CVD 事件发生率，干预对PA和久坐行为的影响，以及将PA行为与PA行为相关的新数据 CVD端点，修订的功率计算表明，我们只有65％的功率来评估 干预CVD事件。我们估计另外4年的随访（总体8年）将产生 85-89％的权力提供了对主要Whish假设的确定测试。此申请建议 将结果的干预和随访延长4年，以便试验可以达到 关于PA干预的收益和风险的确定性结论。我们还建议利用数据和 在计划的延期研究中，生物循环收集在家访问中，以评估关键标记 健康的CVD衰老，包括身体表现，睡眠时间和失眠症状和抑郁症 症状。试点研究将进行执行，以探讨Whish干预对变化的长期影响 已知或发布的生物标志物已知或发表在PA级别的影响，并指示各种 与CVD衰老有关的基本机制。 Whish的结果，无论是积极，无效还是广告， 可以影响健康简历衰老的PA传播计划的未来。