Department of Rehabilitation Sciences and Physiotherapy (MOVANT), University of Antwerp, Antwerpen, Belgium
Clinical Trial Center, University Hospital Antwerp, Edegem, Belgium.
BMJ Open. 2023 Jun 2;13(6):e071098. doi: 10.1136/bmjopen-2022-071098.
Long COVID is a prevalent condition with many multisystemic symptoms, such as fatigue, dyspnoea, muscle weakness, anxiety, depression and sleep difficulties, impacting daily life and (social and physical) functioning. Pulmonary rehabilitation (PR) may improve physical status and symptoms of patients with long COVID, yet the evidence is limited. Therefore, this trial aims to study the effect of primary care PR on exercise capacity, symptoms, physical activity and sleep in patients with long COVID.
PuRe-COVID is a prospective, pragmatic, open-label, randomised controlled trial. A sample of 134 adult patients with long COVID will be randomised to a 12 week PR programme in primary care, supervised by a physiotherapist or to a control group, following no PR. A 3 month and 6 month follow-up period is foreseen. The primary endpoint will be the change in exercise capacity measured by 6-minute walk distance (6MWD) at 12 weeks, hypothesising a more significant improvement in the PR group. Other parameters, such as pulmonary function tests (including maximal inspiratory pressure/maximal expiratory pressure), patient-reported outcomes (COPD Assessment Test, modified Medical Research Council Dyspnoea Scale, Checklist Individual Strength, post-COVID-19 Functional Status, Nijmegen questionnaire, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment Questionnaire and EuroQol-5D-5L), physical activity measured by an activity tracker, hand grip strength and sleep efficiency, are secondary and exploratory outcomes.The recruitment started on 19 April 2022, and 52 patients were included as of 14 December 2022.
Ethical approval was obtained in Belgium from the relevant institutional review boards on 21 February 2022 (Antwerp University Hospital, approval number 2022-3067) and on 1 April 2022 (Ziekenhuis Oost-Limburg in Genk, approval number Z-2022-01). Findings from this randomised controlled trial will be disseminated in peer-reviewed publications and presentations at international scientific meetings.
NCT05244044.
长新冠是一种常见病症，有许多多系统症状，如疲劳、呼吸困难、肌肉无力、焦虑、抑郁和睡眠困难，影响日常生活和（社会和身体）功能。肺康复（PR）可能改善长新冠患者的身体状况和症状，但证据有限。因此，本试验旨在研究初级保健 PR 对长新冠患者的运动能力、症状、身体活动和睡眠的影响。
PuRe-COVID 是一项前瞻性、实用、开放标签、随机对照试验。将 134 名成年长新冠患者随机分为 12 周的初级保健 PR 方案组，由物理治疗师监督，或对照组，不进行 PR。预计有 3 个月和 6 个月的随访期。主要终点是 12 周时 6 分钟步行距离（6MWD）测量的运动能力变化，假设 PR 组有更显著的改善。其他参数，如肺功能测试（包括最大吸气压力/最大呼气压力）、患者报告的结果（COPD 评估测试、改良医学研究委员会呼吸困难量表、个体力量检查表、新冠后功能状态、尼美根问卷、医院焦虑和抑郁量表、工作效率和活动障碍问卷以及 EuroQol-5D-5L）、活动追踪器测量的身体活动、手握力和睡眠效率，为次要和探索性结果。招募工作于 2022 年 4 月 19 日开始，截至 2022 年 12 月 14 日，已纳入 52 名患者。
2022 年 2 月 21 日，相关机构审查委员会在比利时安特卫普大学医院（批准号 2022-3067）和 2022 年 4 月 1 日在根特的 Ziekenhuis Oost-Limburg（批准号 Z-2022-01）获得了伦理批准。这项随机对照试验的结果将在同行评议的出版物和国际科学会议上的演讲中发表。
NCT05244044。
