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: 10341851
• 负责人: Amy M Pastva
• 金额: $ 92.02万
• 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/10341851
• 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; 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; Ultrasonography; 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

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.

COVID-19的严重疾病需要20％的成年人住院，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正在幸免于19 Covid-19危重疾病，但 像其他ICU冲浪者一样，大多数人将在身体机能和 运动能力，新发育残疾，肌肉浪费/无力和新的认知缺陷。这些困难， ICU后数月至数年可以持续存在，被称为强化后护理综合征（PICS） 在199年生存中可能更为严重。尽管文学证明了身体的好处 COVID-19和其他ICU表面的康复，可用的选项和数据有限，可以支持 最佳院后物理康复策略。结合很难进行康复 在大流行期间住院后的人，解决了Covid-19的这种“康复大流行” 代表了巨大的公共卫生挑战。先前研究了ICU中家庭身体康复的研究 幸存者在没有个性化锻炼处方的情况下利用了无监督的运动培训，没有 在通过生理数据（例如心率）积极监测和靶向锻炼的同时，这样做了 力量与平衡训练。在虚弱的老年患者中，高强度间隔训练（HIIT）是安全的，并且 与心肺适应性（CRF）的显着改善（仅在两周内）有关 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资助的第一阶段试点研究表明，HIIT在衰弱的老年人癌症中的安全性和可行性。 遵守运动为117％（这意味着患者的运动超过建议/周/周的建议更多）， 遵守心率目标是98％（这意味着患者实际上是在做HIIT与较少的人。 锻炼），平均患者改善了CRF，如vo2peak在心肺运动时测量 测试25％。我们方法的关键是我们的MHealth平台，在该平台中为患者提供了苹果手表 iPhone预装了我们的软件，允许我们在每次练习后远程下载数据 通过视频会议在家庭环境中提供个性化的上课。作为重症疾病的生存，包括 COVID-19 ICU表面表面，CRF受损（类似于试点研究中的患者）和其他图片表现， 类似的受监控，个性化，结构化和进行性的多域身体康复干预 在改善恢复的可能性很大，但尚未在Covid-19表面上进行研究。解决 在知识上，我们将随机将140 Covid-19 ICU生存归还给我们的远程 受到监测的，移动健康支持的高强度间隔训练后，COVID-19危急疾病（REMM-HIIT-COVID- 19）研究检验以下假设：REMM-HIIT运动干预与仅运动教育相反 改善CRF和肌肉力量/质量（AIM 1）；改善身体功能和生活质量（AIM 2）；并改善 线粒体功能和注射的标记（AIM 3）在出院后3个月测得。