Evaluating a Comprehensive Multimodal Outpatient Rehabilitation Program to Improve the Functioning of Persons Suffering from Post-acute Sequelae of SARS-CoV-2 infection (PASC): A Randomized Controlled

约10%至20%的SARS CoV-2感染者将经历SARS急性后遗症的持续- CoV-2感染(这里称为PASC)。鉴于持续症状与多系统的异质性 参与，最近的共识建议表明，全面的康复计划可能是 需要管理PASC和恢复功能。在新出现的门诊COVID提供的治疗 康复诊所正在了解以前类似的疾病，很有必要更好地了解 不断增长的人口的独特需求以及需要经过检验的、有效的康复计划 他们。我们在这里提供了这两种服务。具体地说，我们的目标是：(1)量化PASC的发生率和严重性 不同变种及其对健康和功能的影响；(2)开发和评估 以患者为中心、跨学科、多模式的综合康复计划的有效性 PASC患者；及(3)估计与拟议PASC康复相关的费用 并研究干预的成本和有效性之间的关系，以及它们之间的关系 对康复计划倡议的影响。来自大型和多样化的正在进行的纵向调查的数据 在研究卫生系统进行新冠肺炎检测的人将作为抽样框架，从 确定PASC患者并将其纳入研究。为期六周的目标计划将由一组核心内容组成 包括个人滴定的伸展和柔韧，加强辅助呼吸 肌肉和横隔膜，阻力和有氧调节，以及前庭康复，补充 根据患者需要量身定做的神经心理和认知治疗。使用随机对照试验 (RCT)设计，干预的有效性将与常规护理的有效性进行比较，并增加一项- 时间面对面评估和患者教育材料。除了步行速度，一种被广泛使用的全球 有氧能力和耐力的测量，以及患者报告的健康和功能(主要结果)， 我们将评估干预的有效性：(I)认知功能，(Ii)疼痛，(Iii)疲劳，(Iv)紧张， 压力、焦虑和抑郁，以及(V)PASC症状的自我管理(次要结果)。 结果将在8周(治疗结束后不久)和90天后的固定时间点进行测量 研究后条目，以检查效果的可持续性。我们的首要假设是更高的 干预组的干预成本将被结果的更大改善所抵消 这意味着，总的来说，干预组的患者将得到比平时更具成本效益的护理 护理小组。鉴于缺乏关于有效评估和治疗的严谨科学证据 PASC和关于获得和价值COVID后康复护理的悬而未决的问题， 这项研究的结果将对政策和项目发展产生重大影响。

About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute sequelae of SARS- CoV-2 infection (referred here as PASC). Given that persistent symptoms are heterogeneous with multisystem involvement, recent consensus recommendations suggest that a holistic rehabilitation program may be required to manage PASC and restore function. While treatments offered at emerging outpatient COVID recovery clinics are being informed by previous similar diseases, the need is great for a better understanding of the unique needs of this growing population and for tested, efficacious rehabilitation programs to address them. We provide both here. Specifically, our aims are: (1) To quantify the incidence and severity of PASC across different variants and their effects on health and functioning; (2) To develop and evaluate the effectiveness of a patient-centered, interdisciplinary, multimodal comprehensive rehabilitation program among patients with PASC; and (3)To estimate the costs associated with the proposed PASC rehabilitation intervention and to examine the relationship between intervention’s costs and effectiveness and their implication for rehabilitation program initiatives. Data from a large and diverse ongoing longitudinal survey of persons who tested for COVID-19 at the study health system will serve as the sampling frame from which to identify and enroll PASC patients in the study. The targeted six-week program will be comprised of a core set of therapies, including individually titrated stretching and flexibility, strengthening of accessory breathing muscles and diaphragm, resistance and aerobic conditioning, and vestibular rehabilitation, supplemented by neuropsychological and cognitive remediation tailored to patients’ needs. Using a randomized controlled trial (RCT) design, the effectiveness of the intervention will be compared to that of usual care augmented by a one- time in-person assessment and patient education materials. In addition to walking speed, a widely used global measure of aerobic capacity and endurance, and patient-reported health and functioning (primary outcomes), we will assess the intervention effectiveness on: (i) cognitive functioning, (ii) pain, (iii) fatigue, (iv) tension, stress, anxiety, and depression, and (v) self-management of PASC symptoms (secondary outcomes). Outcomes will be measured at fixed points in time at 8 weeks (shortly after therapy completion) and at 90 day’s post- study entry to examine sustainability of effects. Our overarching hypothesis is that that higher intervention costs in the intervention group will be more than offset by greater improvements in outcomes implying that, overall, persons in the intervention group will receive more cost-effective care than those in usual care group. Given the dearth of rigorous scientific evidence regarding effective assessment and treatment of PASC and the unresolved questions concerning access to and value of post-COVID rehabilitation care, the results of this study will have significant implications for both policy and program development.