PMID- 37270195 OWN - NLM STAT- MEDLINE DCOM- 20230605 LR - 20230622 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 13 IP - 6 DP - 2023 Jun 2 TI - Randomised, controlled, open-label pragmatic trial evaluating changes in functional exercise capacity after primary care PUlmonary REhabilitation in patients with long COVID: protocol of the PuRe-COVID trial in Belgium. PG - e071098 LID - 10.1136/bmjopen-2022-071098 [doi] LID - e071098 AB - INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05244044. CI - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Volckaerts, Tess AU - Volckaerts T AUID- ORCID: 0000-0003-4490-5381 AD - Department of Rehabilitation Sciences and Physiotherapy (MOVANT), University of Antwerp, Antwerpen, Belgium tess.volckaerts@uza.be. AD - Clinical Trial Center, University Hospital Antwerp, Edegem, Belgium. FAU - Vissers, Dirk AU - Vissers D AD - Department of Rehabilitation Sciences and Physiotherapy (MOVANT), University of Antwerp, Antwerpen, Belgium. FAU - Burtin, Chris AU - Burtin C AD - REVAL-Rehabilitation Research Center, Faculty of Rehabilitation Sciences, BIOMED Biomedical Research Institute, Hasselt University, Hasselt, Belgium. FAU - Van Meerbeeck, Xavier AU - Van Meerbeeck X AD - Department of Pulmonary Medicine, University Hospital Antwerp, Edegem, Belgium. FAU - de Soomer, Kevin AU - de Soomer K AD - Department of Pulmonary Medicine, University Hospital Antwerp, Edegem, Belgium. FAU - Oostveen, Ellie AU - Oostveen E AD - Department of Pulmonary Medicine, University Hospital Antwerp, Edegem, Belgium. FAU - Claes, Kim AU - Claes K AD - Clinical Trial Center, University Hospital Antwerp, Edegem, Belgium. FAU - Roelant, Ella AU - Roelant E AD - Clinical Trial Center, University Hospital Antwerp, Edegem, Belgium. FAU - Verhaegen, Iris AU - Verhaegen I AD - Clinical Trial Center, University Hospital Antwerp, Edegem, Belgium. FAU - Thomeer, Michiel AU - Thomeer M AD - Department of Pulmonary Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium. AD - Faculty of Medicine and Life Science, Hasselt University, Hasselt, Belgium. FAU - Criel, Maarten AU - Criel M AD - Department of Pulmonary Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium. FAU - Quadflieg, Kirsten AU - Quadflieg K AD - REVAL-Rehabilitation Research Center, Faculty of Rehabilitation Sciences, BIOMED Biomedical Research Institute, Hasselt University, Hasselt, Belgium. FAU - Cops, Dries AU - Cops D AD - REVAL-Rehabilitation Research Center, Faculty of Rehabilitation Sciences, BIOMED Biomedical Research Institute, Hasselt University, Hasselt, Belgium. FAU - Ruttens, David AU - Ruttens D AD - Department of Pulmonary Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium. AD - Faculty of Medicine and Life Science, Hasselt University, Hasselt, Belgium. FAU - Lapperre, Therese S AU - Lapperre TS AD - Department of Pulmonary Medicine, University Hospital Antwerp, Edegem, Belgium. AD - Laboratory of Experimental Medicine and Pediatrics, University of Antwerp, Antwerpen, Belgium. LA - eng SI - ClinicalTrials.gov/NCT05244044 PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230602 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Adult MH - Humans MH - *COVID-19 MH - Post-Acute COVID-19 Syndrome MH - Hand Strength MH - Belgium MH - Exercise Tolerance MH - Prospective Studies MH - Exercise MH - Dyspnea/etiology/rehabilitation MH - Primary Health Care MH - Quality of Life MH - Randomized Controlled Trials as Topic PMC - PMC10255055 OTO - NOTNLM OT - COVID-19 OT - medical education & training OT - primary care COIS- Competing interests: None declared. EDAT- 2023/06/04 01:08 MHDA- 2023/06/05 06:42 PMCR- 2023/06/02 CRDT- 2023/06/03 20:53 PHST- 2023/06/05 06:42 [medline] PHST- 2023/06/04 01:08 [pubmed] PHST- 2023/06/03 20:53 [entrez] PHST- 2023/06/02 00:00 [pmc-release] AID - bmjopen-2022-071098 [pii] AID - 10.1136/bmjopen-2022-071098 [doi] PST - epublish SO - BMJ Open. 2023 Jun 2;13(6):e071098. doi: 10.1136/bmjopen-2022-071098.