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

家庭数字运动训练计划可改善老年脓毒症幸存者的身体功能 — HEAL Sepsis 试验

• 批准号: 10353548
• 负责人: Robert T Mankowski
• 金额: $ 22.88万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-15 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10353548
• 关键词: Accelerometer; Address; Aerobic Exercise; Affect; Age; Aging; Body Weight; Cessation of life; Charge; Chronic; Clinical Trials; Control Groups; Critical Illness; Custom; Data; Distant; Elderly; Enrollment; Equilibrium; Exercise; Face; Goals; Health; Health Diary; Health Status; Health care facility; Hip region structure; Home; Hospitals; Infection; Inflammation; Institutes; Institution; Intervention; Location; Marble; Measures; Mobile Health Application; Multiple Organ Failure; Muscular Atrophy; National Heart, Lung, and Blood Institute; National Institute on Deafness and Other Communication Disorders; Occupational Therapy; Older Population; Outcome; Participant; Patients; Physical Function; Physical Performance; Physical activity; Physical therapy; Randomized; Rehabilitation therapy; Research; Risk; Safety; Sepsis; Site; Skilled Nursing Facilities; Standardization; Stretching; Structure; Supervision; Survivors; Tablets; Testing; Text Messaging; Therapeutic; Time; Training Programs; Travel; Treatment Efficacy; United States National Institutes of Health; Visit; Walking; acute care; aged; base; comorbidity; digital; disability; disability risk; exercise intervention; exercise prescription; exercise program; exercise training; feasibility testing; fitness; follow-up; functional decline; functional improvement; functional status; gain of function; group intervention; high risk; high risk population; hospital readmission; improved; improved functioning; intervention program; novel; novel strategies; older patient; physically handicapped; prevent; recruit; remote monitoring; research facility; response; retention rate; safety and feasibility; safety testing; sedentary; standard care; walking speed

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.

摘要 脓毒症是对感染的一种夸张反应，影响所有年龄段，但在老年人中更为普遍。老年 败血症幸存者通常被送到长期急性护理机构，在那里他们通常在1年内死亡。 我们认为，那些从医院回家的人失去了身体机能改善的动力 在早期住院康复后，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较差， 脓毒症后至少持续1年的功能，与年轻的幸存者相比，老年患者不会恢复 它们的功能。我们的老龄化研究表明，身体活动干预可以预防行动不便， 健康的老年人，但老年脓毒症幸存者将深刻脆弱，更多的久坐不动，低- 功能正常，不太可能旅行参加监督运动训练 在我们的研究设施中。目前我们还没有发现任何家庭治疗 改善老年脓毒症幸存者身体功能的方法。当前的移动的健康应用可以 提供结构化的家庭锻炼计划，以达到日常活动目标。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多个化身引导的 强化，平衡和有氧运动，沿着23项标准化评估和个人健康 日记这种数字化和远程监控的运动训练计划可能对败血症幸存者有希望， 健康状况不佳，不太可能旅行参加运动干预。我们提出的 一项研究将测试一种新的12周体力活动干预的安全性、可行性和有效性， 老年脓毒症幸存者的身体功能，利用基于应用程序的数字运动训练平台。我们提出 随机选择40名出院回家时SPPB评分<6的脓毒症幸存者（年龄>65岁） 从医院转移到干预组或标准护理对照组。两组都将收到一台平板电脑， BMHP应用程序，其中包含所有的身体功能评估，和健康日记。干预组 还将收到个性化的化身指导练习以及短信提醒，以锻炼30分钟 每天，每周5天。对于对照组，参与者将使用BMHP健康记录他们的日常活动 日记研究协调员将每周打电话给所有参与者，询问他们的健康状况，并提醒他们 让他们给平板电脑充电。在基线和12周随访时，参与者将使用该应用程序完成应用程序- 指导身体功能评估，我们将使用臀部佩戴的加速度计测量活动水平。这 该项目将是第一个测试数字身体活动干预的安全性，可行性和有效性的项目。 老年脓毒症幸存者的高危人群。结果将提供关于可行性的关键信息， 耐受性和这种新方法增强这些患者身体功能的有效性。