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远程康复干预在 COVID-19 出院患者中以改善功能能力和生活质量。一项多中心随机临床试验的研究方案。

Telerehabilitation Intervention in Patients with COVID-19 after Hospital Discharge to Improve Functional Capacity and Quality of Life. Study Protocol for a Multicenter Randomized Clinical Trial.

机构信息

Department of Physiotherapy, Faculty of Health Science, University of Granada, 18071 Granada, Spain.

Department of Physiotherapy, Faculty of Health Science, University of Malaga, 29071 Málaga, Spain.

出版信息

Int J Environ Res Public Health. 2021 Mar 12;18(6):2924. doi: 10.3390/ijerph18062924.

Abstract

COVID-19 can cause important sequels in the respiratory system and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Physiotherapy interventions acquire a fundamental role in the recovery of the functions and the quality of life. Regarding the recovery phases after hospital discharge, the current evidence available is very preliminary. Telerehabilitation is presented as a promising complementary treatment method to standard physiotherapy. The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center. As secondary objectives, to identify the satisfaction and perception of patients with the telerehabilitation intervention and the presence of barriers to its implementation, as well as to evaluate the cost-effectiveness from the perspective of the health system. This study protocol will be carried out through a single blind multicenter randomized clinical trial in the south of Spain. We hypothesize that the implementation of a telerehabilitation program presents results not inferior to those obtained with the current standard intervention. If the hypothesis is confirmed, it would be an opportunity to define new policies and interventions to address this disease and its consequences. Trial registration NCT04742946.

摘要

COVID-19 可能会在呼吸系统中引起重要的后遗症,经常表现为乏力、呼吸困难、多发性神经病和多器官损伤。物理疗法干预在恢复功能和生活质量方面发挥着重要作用。关于出院后的恢复阶段,目前可用的证据非常初步。远程康复被认为是标准物理疗法的一种有前途的补充治疗方法。这项研究的主要目的是评估与康复中心的健康教育和/或护理方案相比,出院后个性化远程康复干预在改善功能能力和生活质量方面的有效性。作为次要目标,确定患者对远程康复干预的满意度和看法,以及实施该干预的障碍,并从卫生系统的角度评估其成本效益。本研究方案将在西班牙南部进行一项单盲多中心随机临床试验。我们假设远程康复方案的实施结果不劣于当前标准干预的结果。如果假设得到证实,这将是确定新政策和干预措施以应对这种疾病及其后果的机会。试验注册 NCT04742946。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6408/7999591/0b14ed50d492/ijerph-18-02924-g001.jpg

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