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: 10274794
• 负责人: Charles L Kooperberg
• 金额: $ 111.95万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH 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 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10274794
• 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; 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.

这是女性健康倡议 (WHI) 强健健康 (WHISH) 的竞争性更新申请 预计到那时，美国 65 岁及以上的人口数量将从目前的 4900 万增加到 9500 万。 到 2060 年，女性数量远远超过男性，尤其是 85 岁及以上的成年人。 支持以下假设：体力活动 (PA) 可减少心血管 (CV) 疾病 (CVD)， WHISH 是一个里程碑， 务实的随机对照试验，测试集中的公共卫生干预措施是否旨在 增加和/或维持 PA 水平并减少久坐行为将减少主要 CVD（MI、中风、CV 死亡）在老年女性中使用随机同意设计来模拟现实世界的程序化。 WHISH 将 WHI 扩展研究中的 49,333 名合格参与者随机分配到行为组 2015 年 5 月的干预与常规随访。干预组的被动同意过程 (n=24,663) 导致<4% 的女性“选择退出”接受 WHISH 提供的干预材料。 基于 2008 年和 2018 年 DHHS PA 指南的有针对性的、适应性的、指导性干预，旨在 使用季节性通讯、手册、补充国家老龄化研究所 (NIA) 的 Go4Life® 活动 计步器、阻力带、电话和电子邮件激励信息以及专为老年人设计的网站 干预措施根据年度调查的参与者反馈和有关活动的其他意见进行调整。 偏好，并根据其当前的 PF 和 PA 水平进行定制和针对主要有效性和安全性。 在整个随机队列结束时使用意向治疗来评估结果（CVD、骨折）。 在当前的资助期内（2020 年 2 月），将根据 WHISH 观察到的 CVD 进行 4 年的随访。 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 WHI 数据 CVD 终点、修订后的功效计算表明我们将只有 65% 的功效来评估 CVD 的影响 我们估计 WHISH 对 CVD 事件的干预还需要 4 年的随访（总共 8 年）。 85-89% 的功效可提供主要 WHISH 假设的明确检验。 将 WHISH 干预和结果随访再延长 4 年，以便试验能够达到 我们还建议利用数据和关于 PA 干预的益处和风险的明确结论。 在计划的 WHI 扩展研究家访中收集生物样本，以评估关键标记物 健康的心血管疾病衰老，包括身体机能、睡眠时间和失眠症状，以及抑郁 将进行试点研究，以探索 WHISH 干预对症状变化的长期影响。 已知或假定受 PA 水平和各种指标影响的已建立和新颖的生物标志物 与 CVD 衰老相关的潜在机制。 WHISH 的结果，无论是积极的、无效的还是消极的， 可能会对健康CV老龄化的PA传播计划的未来产生巨大的转化影响。