Home-based digital exercise training program to improve physical function of older sepsis survivors – HEAL Sepsis Trial

摘要 败血症是一种对感染的夸大反应，影响各个年龄段，但在老年人中更为普遍。更老的 败血症幸存者通常被送往长期的急性护理机构，在那里他们通常在一年内死亡。 我们认为，那些从医院回家的人失去了身体功能改善的势头 早期住院康复后，经常面临合并症的加重和身体功能的下降。 根据我们的纵向观察数据，老年脓毒症幸存者的健康状况和身体状况都很差 脓毒症后功能持续至少1年，与年轻幸存者相比，老年患者不会恢复 它们的功能。我们的老龄化研究表明，体力活动干预可以预防行动不便。 健康的老年人，但老年败血症幸存者将更加虚弱，更久坐，更低- 工作正常，不太可能有能力出差参加有监督的运动训练 在我们的研究设施中的项目。目前，我们还不知道有任何基于家庭的治疗 改善老年脓毒症幸存者身体功能的方法。当前的移动医疗应用程序可以 提供有组织的居家锻炼计划，以实现日常活动目标。例如，蓝色大理石 健康平台(BMHP)，在NIH的支持下开发和验证，包含100多个化身指导 加强、平衡和有氧运动，以及23项标准化评估和个人健康 日记。这一数字和远程监控的运动训练计划可能会对患有脓毒症的幸存者很有希望 健康状况不佳，不太可能出差参加运动干预。我们的建议 这项研究将测试一种新的为期12周的体育活动干预的安全性、可行性和有效性，以改善 使用基于APP的数字运动训练平台对老年脓毒症幸存者的身体功能。我们建议 对40名败血症幸存者(年龄65岁)在出院回家时用SPPB评分6进行随机分组 从医院进入干预组或标准护理对照组。两组都将收到一台平板电脑，上面有 BMHP应用程序，其中包含所有的身体功能评估，以及健康日记。干预组 还将收到个性化的化身指导练习以及30分钟的短信提醒 每天5天，每周5天。对于控制组，参与者将使用BMHP健康记录他们的日常活动 日记。研究协调员每周会打电话给所有参与者，询问他们的健康状况，并提醒 让他们给药片充电。在基线和12周的随访中，参与者将使用该应用程序完成该应用程序- 指导身体功能评估，我们将使用髋部佩戴的加速计测量活动水平。这 该项目将第一个测试数字身体活动干预的安全性、可行性和有效性 老年败血症幸存者的高危人群。结果将提供关于可行性的关键信息， 这种新方法的耐受性和有效性，以增强这些患者的身体功能。

ABSTRACT Sepsis, an exaggerated response to infection, affects all ages, but it is more prevalent in older adults. Older sepsis survivors are commonly discharged to long-term acute care facilities, where they often die within 1 year. We believe that those who return home from the hospital lose the momentum of physical function improvement after early in-hospital rehabilitation and often face exacerbation of comorbidities and decline in physical function. Based on our longitudinal observational data, older sepsis survivors have poor health status and physical function lasting at least 1 year after sepsis, and in contrast with younger survivors, older patients do not regain their function. Our aging research suggests that physical activity interventions prevent mobility disability in rather healthy older adults, but older sepsis survivors will be profoundly frailer, more sedentary, lower- functioning and will unlikely be capable of traveling to participate in supervised exercise training programs in our research facilities. Currently, we are unaware of any home-based therapeutic approaches to improve physical function of older sepsis survivors. Current mobile health applications can deliver structured home-based exercise programs to reach daily activity goals. For example, the Blue Marble Health Platform (BMHP), developed and validated with the support of NIH contains over 100 avatar-guided strengthening, balance, and aerobic exercises, along with 23 standardized assessments and a personal health diary. This digital and remotely monitored exercise training program might be promising for sepsis survivors with poor health status, who are unlikely to be able to travel to participate in exercise interventions. Our proposed study will test the safety, feasibility and efficacy of a novel 12-week physical activity intervention to improve physical function in older sepsis survivors utilizing an app-based digital exercise training platform. We propose to randomize 40 sepsis survivors (aged >65 years) with an SPPB score <6 at the time of their discharge to home from the hospital into the intervention or a standard care control group. Both groups will receive a tablet with the BMHP app, which contains all of the physical function assessments, and a health diary. The intervention group will also receive personalized avatar-guided exercises as well as text message reminders to exercise for 30min each day, 5 days/week. For the control group, participants will record their daily activities using the BMHP health diary. A research coordinator will call all participants weekly to ask questions about their health status and remind them to charge the tablets. At baseline and 12-week follow-up, participants will use the app to complete the app- guided physical function assessments and we will measure activity levels using hip-worn accelerometers. This project will be the first to test the safety, feasibility and efficacy of a digital physical activity intervention in this high-risk population of older sepsis survivors. The results will provide critical information regarding the feasibility, tolerability, and efficacy of this novel approach to enhance these patients’ physical function.