RT Journal Article
SR Electronic
T1 Randomised, controlled, open-label pragmatic trial evaluating changes in functional exercise capacity after primary care <em>PU</em>lmonary <em>RE</em>habilitation in patients with long COVID: protocol of the PuRe-COVID trial in Belgium
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e071098
DO 10.1136/bmjopen-2022-071098
VO 13
IS 6
A1 Volckaerts, Tess
A1 Vissers, Dirk
A1 Burtin, Chris
A1 Van Meerbeeck, Xavier
A1 de Soomer, Kevin
A1 Oostveen, Ellie
A1 Claes, Kim
A1 Roelant, Ella
A1 Verhaegen, Iris
A1 Thomeer, Michiel
A1 Criel, Maarten
A1 Quadflieg, Kirsten
A1 Cops, Dries
A1 Ruttens, David
A1 Lapperre, Thérèse S
YR 2023
UL http://bmjopen.bmj.com/content/13/6/e071098.abstract
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.