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

基本信息

批准号：
10582663
负责人：
Robert T Mankowski
金额：
$ 19.06万
依托单位：
UNIVERSITY OF FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-15 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10582663
关键词：
Accelerometer Address Aerobic Exercise Affect Age Aging Body Weight Cessation of life Charge Chronic Clinical Trials Control Groups Critical Illness Data Distant Elderly Eligibility Determination Enrollment Equilibrium Exercise Face Goals Health Health Diary Health Status Health care facility Hip region structure Home Hospitals Infection Inflammation Institution Intervention Learning 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 Reduction Safety Sepsis Site Skilled Nursing Facilities Standardization Stretching Structure Survivors Tablets Testing Text Messaging Therapeutic Time Training Programs Travel Treatment Efficacy United States National Institutes of Health Visit Walking acute care aged comorbidity digital digital delivery digital monitoring disability disability risk efficacy evaluation 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 intervention program novel novel strategies older patient physically handicapped prevent recruit remote monitoring research facility response retention rate safety testing sedentary standard care walking speed

项目摘要

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.

抽象的败血症是对感染的一种过度反应，影响所有年龄段，但在老年人中更为普遍。脓毒症幸存者通常会被送往长期急性护理机构，他们通常会在一年内死亡。我们相信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，经常面临合并症的恶化和身体功能的下降。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较差败血症后功能持续至少 1 年，与年轻幸存者相比，老年患者不会恢复我们的衰老研究表明，身体活动干预措施可以预防行动障碍。健康的老年人，但老年脓毒症幸存者将更加虚弱，更久坐，身体素质较低功能正常，不太可能前往参加监督下的运动训练目前，我们不知道有任何家庭治疗方案。当前的移动医疗应用可以改善老年脓毒症幸存者的身体机能。提供结构化的家庭锻炼计划以实现日常活动目标，例如 Blue Marble。健康平台 (BMHP) 在 NIH 的支持下开发和验证，包含 100 多个虚拟形象引导力量、平衡和有氧运动，以及 23 项标准化评估和个人健康这种数字化和远程监控的运动训练计划可能对脓毒症幸存者有希望。健康状况不佳，不太可能前往参加运动干预。研究将测试一种新颖的为期 12 周的身体活动干预措施的安全性、可行性和有效性，以改善我们建议利用基于应用程序的数字运动训练平台来改善老年脓毒症幸存者的身体功能。将 40 名脓毒症幸存者（年龄 >65 岁）随机分组，出院回家时 SPPB 评分 <6 从医院进入干预组或标准护理对照组，两组都将收到含有该药物的药片。 BMHP 应用程序，其中包含所有身体功能评估和健康日记干预组。还将收到个性化头像指导锻炼以及锻炼 30 分钟的短信提醒每天，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。研究协调员每周都会给所有参与者打电话，询问他们的健康状况并提醒他们。在基线和 12 周的随访中，参与者将使用该应用程序来完成该应用程序 - 指导身体功能评估，我们将使用髋部佩戴的加速度计测量活动水平。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风险人群的结果将提供有关可行性的关键信息，这种新方法增强这些患者身体机能的耐受性和有效性。