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: 10688242
• 负责人: Charles L Kooperberg
• 金额: $ 177.68万
• 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/10688242
• 关键词: Address; Adult; Aerobic; Aging; 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; Data; Data Collection; Educational Intervention; Elderly; Electronic Mail; Ensure; Equilibrium; 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; Randomized; Randomized, Controlled Trials; Resistance; Seasons; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Stroke; Surveys; Symptoms; Telephone; Testing; Troponin T; Woman; Women' s Health; adjudication; cardiovascular disorder risk; cardiovascular health; cohort; depressive symptoms; design; effectiveness outcome; eligible participant; ethnic diversity; exercise intervention; flexibility; follow-up; group intervention; healthy aging; human very old age (85+); improved; improvement on sleep; intervention effect; men; myocardial injury; novel marker; older women; pedometer; pilot test; pragmatic trial; preference; preservation; prevent; program dissemination; programs; public health intervention; racial diversity; 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.

这是妇女健康倡议（WHI）“强壮与健康”（WHISH）的竞争性更新申请。