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.

项目概要 虚弱是一种脆弱的综合症状态，使 65 岁以上的成年人面临更高的不良健康风险 结果。据估计，50% 的美国老年人处于虚弱前期——临床前的虚弱阶段可能更严重。 比虚弱更容易接受干预努力。增加体力活动是一种有希望的干预措施，可以改善身体状况 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 对于久坐的老年人来说，保持习惯性的身体活动是很困难的，特别是那些受困于运动的老年人 健康挑战。 2018 年美国体力活动指南建议所有成年人表现≥150 分钟/周的体力活动并减少久坐行为。然而，传统的方法来增加 体力活动对于减少久坐行为几乎没有作用，特别是对于老年人来说。久坐少 行为与改善的生物和社会心理健康相关——与满足身体条件无关 活动指南。因此，仍然迫切需要实施和评估一种结构化的方法来减少 久坐行为是习惯性体育活动的潜在途径。客观地运用小说 通过测量身体活动指标，我们的研究小组表明，每天的久坐时间，无论是总时间还是 长期积累，与虚弱有关。我们的观察证据表明：1）每天，非 运动 随着年龄的增长，体力活动会减少并变得更加分散（持续时间越长，连续活动就越少） 久坐), 2) 每日久坐时间较长和活动碎片化均与较高水平相关 虚弱发生率，3）久坐时间与虚弱相关炎症标志物呈正相关。我们 提出一项试点研究，其中我们将 60 名体弱多病的社区居住老年人随机分组，接受两种治疗中的一种 干预措施，每次旨在逐渐减少久坐时间：1）持续形成30分钟步行 回合，或 2) 以回合方式组成 3 个 10 分钟步行回合。项目目标是： a) 探索 干预措施内和干预措施之间将客观测量的久坐时间减少超过 2 的有效性 月； b) 评估久坐时间减少与 i) 患者报告的结果和 ii) 虚弱的关联 相关炎症标志物。主要结果是加速度计确定的静坐时间。中学 结果包括活动碎片、患者报告的结果和炎症标志物。与一个 跨学科指导小组，我的职业发展计划建立在我在衰老和身体方面的专业知识之上 活动流行病学，以熟练掌握：1) 为老年人制定和实施临床试验，2) 设计干预措施以改善健康行为，3）进行虚弱和炎症相关的研究 4) 获得成为有效的 PI 和领导者的能力。该项目利用了 约翰·霍普金斯临床与转化研究所 (ICTR) 和比彻姆老年病学中心 医学在支持早期教师方面有着良好的记录。该奖项将有助于我过渡到 独立调查员，还将为 R21 和 R01 应用提供信息数据。