Abramoff Md Benjamin, Dillingham Md Timothy, Rybicki Ma Ms Ava-Kathleen, Shofer Frances, McGinley Mph Ms Emily, Verma Shefali S, Ma Ccc-Slp Monica Coran Kuns, Dpt John T Barry, Pezzin Ph Liliana E
Res Sq. 2025 Aug 18:rs.3.rs-7375832. doi: 10.21203/rs.3.rs-7375832/v1.
About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute sequelae of SARSCoV-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. Data from a large and diverse ongoing longitudinal survey of persons positive for COVID-19 at the study health system will serve as the sampling frame from which to enroll PASC study patients. The targeted six-week program will comprise a core set of therapies including individually titrated isometrics, strengthening of accessory breathing muscles and diaphragm, resistance and aerobic conditioning, and neuropsychological and cognitive remediation tailored to patients' needs. Using a randomized controlled trial design, the effectiveness of the supervised multimodal rehabilitation intervention will be compared to that of a self-guided (active control) group receiving patient education materials adapted from the World Health Organization guidelines for PASC management. 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 intervention effectiveness on: cognitive functioning, pain, fatigue, tension, stress, anxiety, and depression, and self-management of PASC symptoms (secondary outcomes). Outcomes will be measured at 8 weeks and at 90 day's post- study entry to examine sustainability of effects. Recruitment is ongoing. It is unlikely that COVID-19 vaccines will lead to the end of PASC syndrome given the emergence of increasingly infectious variants and the high numbers of individuals with continued symptoms several months from initial infection. High rates of vaccine hesitancy and refusal will also contribute to the persistence of both COVID-19 and PASC. Given the dearth of rigorous scientific evidence regarding effective assessment and treatment of PASC and unresolved questions concerning post-COVID rehabilitation care, the results of this study will have significant implications for both policy and program development. ClinicalTrials.gov ID: NCT06156202.
感染新冠病毒的人中，约10%-20%会出现新冠病毒感染的持续性急性后遗症（在此称为PASC）。鉴于持续症状具有多系统受累的异质性，最近的共识建议表明，可能需要一个全面的康复计划来管理PASC并恢复功能。虽然新兴的门诊新冠康复诊所提供的治疗是根据以前类似疾病的经验，但迫切需要更好地了解这一不断增长的人群的独特需求，并制定经过测试且有效的康复计划来满足这些需求。来自该研究健康系统对新冠病毒检测呈阳性者进行的一项大型、多样化的正在进行的纵向调查的数据，将作为招募PASC研究患者的抽样框架。为期六周的目标计划将包括一组核心疗法，包括根据患者需求进行个体化调整的等长运动、辅助呼吸肌和膈肌强化训练、阻力训练和有氧训练，以及神经心理和认知康复。采用随机对照试验设计，将有监督的多模式康复干预的效果与接受根据世界卫生组织PASC管理指南改编的患者教育材料的自我指导（积极对照）组进行比较。除了步行速度（一种广泛使用的有氧运动能力和耐力的总体指标）以及患者报告的健康和功能状况（主要结局）外，我们还将评估干预对以下方面的效果：认知功能、疼痛、疲劳、紧张、压力、焦虑和抑郁，以及PASC症状的自我管理（次要结局）。结局将在研究开始后的8周和90天进行测量，以检验效果的可持续性。招募工作正在进行中。鉴于传染性越来越强的变异毒株的出现以及大量感染者在初次感染数月后仍有持续症状，新冠疫苗不太可能导致PASC综合征的终结。高比例的疫苗犹豫和拒绝也将导致新冠病毒和PASC的持续存在。鉴于关于PASC有效评估和治疗的严格科学证据匮乏，以及关于新冠后康复护理的未解决问题，本研究结果将对政策和项目发展产生重大影响。ClinicalTrials.gov标识符：NCT06156202。
