The START trial: a proof-of-concept sedentary reduction program for prefrail older adults

START 试验：针对体弱老年人的概念验证减少久坐计划

• 批准号: 10624388
• 负责人: Amal Asiri Wanigatunga
• 金额: $ 13.01万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10624388
• 关键词: Accelerometer; Address; Adult; Age; Aging; American; Anxiety; Award; Behavior; Biological; Biological Markers; Biology; Biometry; Clinical Research; Clinical Trials; Communities; Competence; Conduct Clinical Trials; Data; Development Plans; Dose; Effectiveness; Elderly; Epidemiology; Exercise; Faculty; Fatigue; Geriatrics; Goals; Guidelines; Habits; Health; Health behavior; Incidence; Inflammation; Infrastructure; Interleukin-6; Intervention; Link; Measurement; Measures; Mentored Research Scientist Development Award; Mentors; Moods; Outcome; Pain; Pathway interactions; Patient Outcomes Assessments; Physical activity; Pilot Projects; Population; Psychology; Public Health; Randomized; Recommendation; Records; Research; Research Personnel; Risk; Self Efficacy; Serum; Stress; Structure; System; TNFRSF1A gene; Teacher Professional Development; Testing; Time; Translational Research; Universities; Walking; age related; career development; combat; design; effectiveness evaluation; frailty; human old age (65+); improved; inflammatory marker; meetings; member; novel; pre-clinical; prevent; primary outcome; programs; psychosocial; response; secondary outcome; sedentary; sedentary lifestyle; therapy design

PROJECT SUMMARY Frailty is a syndromic state of vulnerability that puts adults aged ≥65 years at heightened risk of adverse health outcomes. An estimated 50% of older Americans are prefrail—a pre-clinical stage of frailty that might be more amenable to intervention efforts than frailty. Increasing physical activity is a promising intervention to better manage/help reverse the multisystem dysregulation that drives frailty and sequalae. However, initiating and maintaining habitual physical activity is difficult for sedentary older adults, particularly those encumbered by health challenges. The 2018 US Physical Activity Guidelines recommends that all adults perform ≥150 minutes/week of physical activity and reduce sedentary behaviors. Yet, traditional approaches to increase physical activity do little to address sedentary behavior reduction, especially for older adults. Lower sedentary behavior is associated with improved biological and psychosocial health—independent of meeting physical activity guidelines. Thus, there remains a critical need to implement and evaluate a structured way to reduce sedentary behavior as a potential pathway for habitual physical activity engagement. Using novel objectively measured physical activity metrics, our research group has shown that daily sedentary time, either in total or accrued in a prolonged manner, is associated with frailty. Our observation evidence shows that: 1) daily, non- exercise physical activity declines and becomes more fragmented with age (less continuous activity with longer sedentary bouts), 2) higher daily sedentary time and activity fragmentation are both associated with higher frailty incidence, and 3) sedentary time is positively associated with frailty-related markers of inflammation. We propose a pilot study in which we randomize 60 prefrail community-dwelling older adults to receive one of two interventions, each designed to gradually reduce sedentary time: 1) continuously to form a 30-minute walking bout, or 2) in a bouted manner to form three 10-minute walking bouts. Project goals are to: a) explore the effectiveness within and between interventions to decrease objectively measured sedentary time over 2 months; b) assess decreased sedentary time’s association with i) patient-reported outcomes and ii) frailty- related inflammatory markers. The primary outcome is accelerometer-determined sedentary time. Secondary outcomes include activity fragmentation, patient-reported outcomes, and inflammatory markers. With a transdisciplinary mentoring panel, my career development plan builds on my expertise in aging and physical activity epidemiology to gain proficiency in: 1) developing and implementing clinical trials for older adults, 2) designing interventions to improve health behaviors, 3) conducting frailty and inflammation related research and 4) gaining competencies to become an effective PI and leader. This project utilizes the infrastructure of the Johns Hopkins Institute for Clinical and Translational Research (ICTR) and Beacham Center for Geriatric Medicine which have strong records of supporting early-stage faculty. This award will facilitate my transition to an independent investigator and will also provide informative data for R21 and R01 applications.

项目摘要 虚弱是一种脆弱的综合征状态，使≥65岁的成年人处于不利健康的高风险中 结果。据估计，50%的美国老年人是虚弱前期，这是一种虚弱的临床前阶段， 比脆弱更容易被干预增加身体活动是一种有希望的干预措施， 管理/帮助扭转导致虚弱和后遗症的多系统失调。然而，发起和 对于久坐不动的老年人来说，保持习惯性的身体活动是困难的，特别是那些受 健康挑战。2018年美国身体活动指南建议所有成年人进行≥150 5分钟/周的身体活动，减少久坐行为。然而，传统的增加 体育活动对减少久坐行为几乎没有帮助，尤其是对老年人。较低的久坐 行为与改善的生物和心理社会健康相关-独立于会议的身体 活动指南。因此，仍然迫切需要执行和评估一种结构化的方式， 久坐行为作为习惯性身体活动参与的潜在途径。客观地使用小说 测量身体活动指标，我们的研究小组已经表明，每天久坐不动的时间，无论是总的还是 长时间累积，与虚弱有关。我们的观察证据表明：1）每天，非- 锻炼身体活动随着年龄的增长而下降，变得更加分散（随着时间的推移， 久坐不动的发作），2）每日久坐时间和活动碎片都与较高的 虚弱发病率; 3）久坐时间与虚弱相关的炎症标志物呈正相关。我们 我建议进行一项试点研究，我们随机选择60名体弱前社区居住的老年人， 干预措施，每次旨在逐步减少久坐时间：1）连续步行30分钟， 或2）以bouted方式形成三个10分钟的步行回合。项目目标是：a）探索 干预措施内和干预措施之间的有效性，以减少客观测量的久坐时间超过2 月; B）评估久坐时间减少与i）患者报告的结局和ii）虚弱的相关性- 相关炎症标志物。主要结果是加速度计确定的久坐时间。二次 结果包括活动片段化、患者报告的结果和炎症标志物。与 在跨学科指导小组中，我的职业发展计划建立在我在老龄化和身体健康方面的专业知识基础上。 活动流行病学，以获得熟练：1）开发和实施老年人的临床试验，2） 设计干预措施，以改善健康行为，3）进行脆弱和炎症相关的研究 以及4）获得成为有效PI和领导者的能力。该项目利用了 约翰霍普金斯临床和转化研究所（ICTR）和Beacham老年医学中心 医学有很强的支持早期教师的记录。这个奖项将有助于我过渡到 一个独立的调查员，也将提供R21和R 01应用的信息数据。