Remotely Monitored, Mobile health-supported High Intensity Interval Training after COVID-19 Critical Illness (REMM HIIT-Covid19)

COVID-19 危重疾病后远程监控、移动健康支持的高强度间歇训练 (REMM HIIT-Covid19)

• 批准号: 10490892
• 负责人: Amy M Pastva
• 金额: $ 79.91万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10490892
• 关键词: Accelerometer; Address; Adherence; Adipose tissue; Adult; Aging; American; Apple watch; Area; Award; Balance training; Biological Markers; Bone Marrow Transplantation; COVID-19; COVID-19 pandemic; COVID-19 survivors; Cancer Patient; Cardiopulmonary; Caring; Cellular Phone; Clinic; Clinical Research; Clinical Trials; Clinical Trials Design; Cognition; Cognitive deficits; Computer software; Critical Care; Critical Illness; Data; Development; Devices; Disease; Dose; Education; Elderly; Equilibrium; Exercise; Exercise Test; Funding; Future; Glycogen; Goals; Heart Rate; Home; Home environment; Hospitalization; Hospitals; Impairment; Individual; Inflammation; Intensive Care; Intensive Care Units; Interdisciplinary Study; Interval training; Intervention; Intramuscular; Kentucky; Knowledge; Leukocytes; Literature; Malignant Neoplasms; Measures; Medical center; Medicine; Mental Health; Mitochondria; Monitor; Multicenter Studies; Multicenter Trials; Muscle; Muscle function; Muscular Atrophy; Near-Infrared Spectroscopy; Ohio; Operative Surgical Procedures; Outcome; Outcomes Research; Oxygen Consumption; Patient Self-Report; Patients; Performance; Persons; Phase; Physical Exercise; Physical Function; Physical Performance; Physical Rehabilitation; Physiological; Pilot Projects; Population; Public Health; Quality of life; Randomized; Recovery; Rehabilitation therapy; Reporting; Research; Research Institute; Resistance; Societies; Structure; Survivors; Syndrome; Testing; United States National Institutes of Health; Universities; Videoconferencing; Walking; base; brain dysfunction; cardiorespiratory fitness; chemotherapy; digital; disability; exercise capacity; exercise intervention; exercise prescription; exercise training; experience; fitness; functional outcomes; improved; innovation; mHealth; mitochondrial metabolism; muscle form; muscle strength; novel; novel strategies; older patient; pandemic disease; patient safety; physically handicapped; primary endpoint; programs; ranpirnase; rehabilitation research; rehabilitation strategy; remote monitoring; safety and feasibility; severe COVID-19; strength training; survivorship; ultrasound

Severe disease from COVID-19 requires hospitalization in 20% of adults, with a third of those patients requiring intensive care unit (ICU) treatment. While a growing number of patients are surviving COVID-19 critical illness, like other ICU survivors, the majority will experience significant post-hospital disabilities in physical function and exercise capacity, new-onset disability, muscle wasting/weakness, and new cognitive deficits. These difficulties, which can persist for months to years post-ICU, are collectively known as post-intensive care syndrome (PICS) and may be more severe in COVID-19 survivors. Despite literature demonstrating the benefit of physical rehabilitation in COVID-19 and other ICU survivors, there are limited available options and data to support an optimal post-hospital physical rehabilitation strategy. Combined with the difficulties of delivering rehabilitation in- person after hospitalization during a pandemic, addressing this “rehabilitation pandemic” from COVID-19 represents an enormous public health challenge. Previous studies of home-based physical rehabilitation in ICU survivors have utilized unsupervised exercise training without a personalized exercise prescription, and none have done so while actively monitoring and targeting exercise via physiologic data such as heart rate or included strength and balance training. In debilitated older patients, high intensity interval training (HIIT) is safe and associated with significant improvements (in as little as two weeks) in cardiorespiratory fitness (CRF) that also correlates with self-reported physical function and disability. We have evaluated this approach in a successful NIH-funded phase 1 pilot study demonstrating safety and feasibility of HIIT in debilitated older adults with cancer. Adherence to exercise was 117% (meaning patients exercised more than recommended 3 sessions/week), compliance with heart rate goals was 98% (meaning patients were actually doing HIIT vs. less-intensive exercise), and on average patients improved CRF, as measured by VO2peak on cardiopulmonary exercise testing by 25%. The key to our approach is our mHealth platform, in which patients are given Apple Watches and iPhones preloaded with our software allowing us to remotely download data after each exercise session to provide personalized up-coaching via videoconferencing in home setting. As critical illness survivors, including COVID-19 ICU survivors, have impaired CRF (similar to patients in pilot study) and other manifestations of PICS, a similar monitored, personalized, structured, and progressive multi-domain physical rehabilitation intervention has significant potential for improving recovery, but has not yet been studied in COVID-19 survivors. To address this gap in knowledge, we will randomize 140 COVID-19 ICU survivors being discharged home to our REmotely Monitored, Mobile health-supported High Intensity Interval Training after COVID-19 Critical Illness (REMM-HIIT-Covid- 19) study to test the hypothesis that the REMM-HIIT exercise intervention, in contrast to exercise education alone, will improve CRF and muscle strength/mass (Aim 1); improve physical function and quality of life (Aim 2); and improve markers of mitochondrial function and inflammation (Aim 3) measured at 3-months after discharge.

20%的成年人因COVID-19导致的严重疾病需要住院治疗，其中三分之一的患者需要 重症监护室（ICU）治疗。虽然越来越多的患者在COVID-19重症中幸存下来， 像其他ICU幸存者一样，大多数人将经历严重的住院后身体功能残疾， 运动能力、新发残疾、肌肉萎缩/无力和新发认知缺陷。这些困难， 重症监护后综合征（PICS）可持续数月至数年， 在COVID-19幸存者中可能更严重。尽管文献证明了物理治疗的益处， 在COVID-19和其他ICU幸存者的康复中，支持康复的可用选项和数据有限。 最佳的出院后身体康复策略。再加上康复治疗的困难- 在大流行期间住院治疗后的人，解决COVID-19的“康复大流行” 是一个巨大的公共卫生挑战。ICU家庭物理康复的研究进展 幸存者利用无人监督的运动训练，没有个性化的运动处方， 我已经这样做了，同时通过生理数据，如心率或包括 力量和平衡训练。在年老体弱的患者中，高强度间歇训练（HIIT）是安全的， 与心肺适应性（CRF）的显著改善（在短短两周内）相关， 与自我报告的身体功能和残疾相关。我们已经成功地评估了这种方法， NIH资助的1期试点研究证明了HIIT在虚弱的老年癌症患者中的安全性和可行性。 坚持锻炼的比例为117%（意味着患者每周锻炼超过推荐的3次）， 对心率目标的依从性为98%（意味着患者实际上正在进行HIIT，而不是强度较低的HIIT）。 运动），平均而言，患者改善了CRF，通过心肺运动时的VO 2 peak测量 测试25%我们方法的关键是我们的mHealth平台，在这个平台上，患者可以获得Apple Watch iPhone预装了我们的软件，允许我们在每次锻炼后远程下载数据， 通过家庭视频会议提供个性化的辅导。作为重症幸存者，包括 COVID-19 ICU幸存者的CRF受损（类似于试点研究中的患者）和PICS的其他表现， 类似的监测、个性化、结构化和渐进式多领域物理康复干预 具有改善恢复的巨大潜力，但尚未在COVID-19幸存者中进行研究。解决 我们将随机抽取140名COVID-19 ICU幸存者出院回家， COVID-19危重病后的远程、移动的健康支持高强度间歇训练（REMM-HIIT-Covid- 19)一项研究旨在检验REMM-HIIT运动干预的假设，与单独的运动教育相比， 改善慢性肾功能衰竭和肌肉力量/质量（目标1）;改善身体机能和生活质量（目标2）;并改善 出院后3个月测量的线粒体功能和炎症标志物（目标3）。