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

体力活动可改善老年女性的心血管健康：一项务实的试验——DCC

• 批准号: 9010974
• 负责人: Charles L Kooperberg
• 金额: $ 67.22万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-09 至 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9010974
• 关键词: Accelerometer; Address; Adult; Aerobic; Age; Aging; Algorithms; American; Behavior; Behavioral Sciences; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic Disease; Clinical; Cognitive; Communities; Complement; Consent; Coronary; Data; Disease Outcome; Elderly; Eligibility Determination; Enrollment; Equilibrium; Ethnic Origin; Ethnic group; Event; Evidence based intervention; Exercise; Familiarity; Feedback; Fracture; Goals; Health; Hip Fractures; Hour; Human; Individual; Intervention; Ischemic Stroke; Link; Medical Records; Methods; Monitor; Multi-Institutional Clinical Trial; Myocardial Infarction; National Institute on Aging; Observational Study; Older Population; Outcome; Participant; Patient Self-Report; Peripheral arterial disease; Physical Function; Physical activity; Physicians; Population; Population Group; Public Health; Questionnaires; Race; Randomized; Randomized Controlled Trials; Records; Research Design; Research Infrastructure; Resources; Risk; Safety; Strenuous Exercise; Stroke; System; Technology; Testing; Time; United States; United States Centers for Medicare and Medicaid Services; Venous; Voice; Walking; Woman; Women' s Health; adjudication; aged; base; burden of illness; cardiovascular disorder risk; cardiovascular health; cohort; comparison group; cost; design; effective intervention; evidence base; experience; falls; flexibility; follow-up; functional status; improved; indexing; innovation; meetings; mortality; novel; older women; pragmatic trial; prevent; programs; public health intervention; randomized trial; rapid growth; response; screening; secondary outcome; sedentary; sedentary lifestyle; strength training; therapy design

 DESCRIPTION (provided by applicant): The number of Americans aged 65 and older is projected to double to 88.5 million by 2050 (55% women). The significant aging of the U.S. population creates a public health mandate to identify effective interventions for preserving the health and independence of older people, especially women. Compelling evidence over the past several decades supports the importance of physical activity (PA) for preventing cardiovascular (CV) and other chronic diseases, and preserving physical and cognitive health, in older adults. Yet, despite the steady emergence of evidence-based interventions for increasing PA in older adults, which could potentially be delivered at a population level, we lack large-scale randomized trial data showing that these interventions can prevent clinical CV events or impact the public's health. To address this critical gap, we propose to conduct a large-scale, randomized controlled pragmatic trial, the Women's Health Initiative Strong & Healthy (WHISH) trial. This pragmatic trial will be embedded in the large, race/ethnicity diverse, WHI Extension cohort, now aged 63-99 years, which is both novel and resource-efficient. The trial will test the hypothesis that a centralized public health intervention designed to increase and/or maintain PA to levels recommended for older U.S. adults will reduce major CV events (e.g., myocardial infarction (MI), stroke, and CVD death) in older women over ~4 years of follow-up. The study will also evaluate the safety of the intervention by examining risks of total clinical fracture, hi fracture, falls, and non-CVD mortality. Preliminary screening indicates that 50,500 WHI women will meet eligibility criteria; the PA intervention and "usual activity" comparison groups will eac contain ~25,250 participants (mean age ~80 years). We will use a randomized consent design, with the observational comparison group and non-consenters followed as usual within the WHI Extension study. The WHISH intervention builds upon evidence-based, state-of-the-science behavioral approaches and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive strategies to tailor the intervention. We will use an algorithm-driven interactive voice response (IVR) system, a technology of increasing familiarity to older adults, built to complement National Institute on Aging (NIA) Go4Life(R) Exercise & Physical Activity materials. The evidence-based IVR system provides tailored advice, with personalized feedback and a means for self-monitoring (logging activity) and personal goal setting. PA behavior will be monitored by self-reported questionnaire and an accelerometry substudy in both study groups. Based on observed rates in the WHI cohort, we project 80% power to detect a 12.5% effect size for major CV events over the follow-up period. The WHI infrastructure, combined with innovative, evidence-based methods to deliver the PA intervention at a population level, provides a unique opportunity to address the critical question, "Can a public health PA intervention reduce CVD events in older women?" Determining the answer to this question, using a resource-efficient, scalable intervention, has major public health significance.

 描述（由申请人提供）：到 2050 年，65 岁及以上的美国人数量预计将增加一倍，达到 8850 万（其中 55% 为女性）。美国人口的严重老龄化催生了一项公共卫生任务，即确定有效的干预措施，以维护老年人（尤其是女性）的健康和独立性。过去几十年的令人信服的证据支持体力活动 (PA) 对于预防心血管 (CV) 和其他慢性疾病以及保持老年人的身体和认知健康的重要性。然而，尽管用于增加老年人 PA 的循证干预措施不断出现，并且有可能在人群水平上实施，但我们缺乏大规模随机试验数据，表明这些干预措施可以预防临床心血管事件或影响公众健康。为了解决这一关键差距，我们建议进行一项大规模、随机对照的实用性试验，即妇女健康倡议强健与健康 (WHISH) 试验。这项务实的试验将纳入目前年龄在 63-99 岁的大型、种族/族裔多样化的 WHI 扩展队列中，这既新颖又资源高效。该试验将检验以下假设：旨在将 PA 增加和/或维持至美国老年人推荐水平的集中公共卫生干预措施将在约 4 年的随访中减少老年女性的主要心血管事件（例如心肌梗死 (MI)、中风和 CVD 死亡）。该研究还将通过检查临床总骨折、骨折、跌倒和非心血管疾病死亡率的风险来评估干预措施的安全性。初步筛选表明，50,500 名 WHI 女性将符合资格标准； PA 干预组和“日常活动”对照组将包含约 25,250 名参与者（平均年龄约 80 岁）。我们将使用随机同意设计，在 WHI Extension 研究中照常跟踪观察对照组和非同意组。 WHISH 干预措施建立在基于证据的、最科学的行为方法和干预措施的基础上，这些方法和干预措施已被证明可有效提高老年女性的 PA，并采用创新的适应性策略来定制干预措施。我们将使用算法驱动的交互式语音应答 (IVR) 系统，这是一种越来越为老年人所熟悉的技术，旨在补充国家老龄化研究所 (NIA) Go4Life(R) 锻炼和身体活动材料。基于证据的 IVR 系统提供量身定制的建议、个性化反馈以及自我监控（记录活动）和个人目标设定的方法。 PA 行为将通过两个研究组的自我报告问卷和加速度计子研究进行监测。根据 WHI 队列中观察到的比率，我们预计在随访期间有 80% 的功效可以检测到主要 CV 事件的 12.5% 效应大小。 WHI 基础设施与创新的、基于证据的方法相结合，在人口层面上提供 PA 干预，为解决以下关键问题提供了独特的机会： “公共卫生 PA 干预措施能否减少老年女性的 CVD 事件？”使用资源高效、可扩展的干预措施来确定这个问题的答案，对公共卫生具有重大意义 意义。