The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium.

Autor: Daynes E; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK. enya.daynes@uhl-tr.nhs.uk.; Department of Respiratory Sciences, University of Leicester, Leicester, UK. enya.daynes@uhl-tr.nhs.uk., Baldwin M; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK., Greening NJ; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Yates T; NIHR Leicester Biomedical Research Centre- Diabetes, Leicester, UK.; Diabetes Research Centre, College of Life Sciences, University of Leicester, Leicester, UK., Bishop NC; National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK., Mills G; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK., Roberts M; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK., Hamrouni M; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK., Plekhanova T; NIHR Leicester Biomedical Research Centre- Diabetes, Leicester, UK.; Diabetes Research Centre, College of Life Sciences, University of Leicester, Leicester, UK., Vogiatzis I; Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, UK., Echevarria C; The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK., Nathu R; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., McAuley HJC; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Latimer L; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Glennie J; The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK., Chambers F; The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK., Penfold R; The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK., Hume E; Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, UK., Megaritis D; Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, UK., Alexiou C; Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, UK., Potthoff S; Department of Social Work, Education, and Community Wellbeing, Northumbria University Newcastle, Newcastle upon Tyne, UK., Hogg MJ; Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, UK., Haighton C; Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, UK., Nichol B; Faculty of Health and Life Sciences, Northumbria University Newcastle, Newcastle upon Tyne, UK., Leavy OC; Department of Health Sciences, University of Leicester, Leicester, UK., Richardson M; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK., Elneima O; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Singapuri A; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Sereno M; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Saunders RM; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Harris VC; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK., Nolan CM; College of Health, Medicine and Life Sciences, Brunel University, London, UK.; Harefield Respiratory Research Group, Guy's and St Thomas' NHS Foundation Trust, London, UK., Bolton C; School of Medicine, The University of Nottingham, Nottingham, UK., Houchen-Wolloff L; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Harrison EM; Department of Health Sciences, University of Leicester, Leicester, UK., Lone N; Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.; Usher Institute, University of Edinburgh, Edinburgh, UK., Quint J; National Heart and Lung Institute, Imperial College London, London, UK., Chalmers JD; Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK., Ho LP; MRC Human Immunology Unit, University of Oxford, Oxford, UK., Horsley A; Division of Infection, Immunity & Respiratory Medicine, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK., Marks M; Hospital for Tropical Diseases, University College London Hospitals, London, UK.; Division of Infection & Immunity, University College London, London, UK., Poinasamy K; Asthma UK and British Lung Foundation, London, UK., Ramen B; Radcliffe Department of Medicine, University of Oxford, Oxford, UK., Wain LV; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Health Sciences, University of Leicester, Leicester, UK., Brightling C; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Man WD; Harefield Respiratory Research Group, Guy's and St Thomas' NHS Foundation Trust, London, UK.; University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.; Harefield Respiratory Research Group, Heart, Lung and Critical Care Clinical Group, Guy's and St Thomas' NHS Foundation Trust, London, UK., Evans R; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK., Singh SJ; NIHR Leicester Biomedical Research Centre-Respiratory, Leicester, UK.; Department of Respiratory Sciences, University of Leicester, Leicester, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Jan 26; Vol. 24 (1), pp. 61. Date of Electronic Publication: 2023 Jan 26.
DOI: 10.1186/s13063-023-07093-7
Abstrakt: Introduction: Many adults hospitalised with COVID-19 have persistent symptoms such as fatigue, breathlessness and brain fog that limit day-to-day activities. These symptoms can last over 2 years. Whilst there is limited controlled studies on interventions that can support those with ongoing symptoms, there has been some promise in rehabilitation interventions in improving function and symptoms either using face-to-face or digital methods, but evidence remains limited and these studies often lack a control group.
Methods and Analysis: This is a nested single-blind, parallel group, randomised control trial with embedded qualitative evaluation comparing rehabilitation (face-to-face or digital) to usual care and conducted within the PHOSP-COVID study. The aim of this study is to determine the effectiveness of rehabilitation interventions on exercise capacity, quality of life and symptoms such as breathlessness and fatigue. The primary outcome is the Incremental Shuttle Walking Test following the eight week intervention phase. Secondary outcomes include measures of function, strength and subjective assessment of symptoms. Blood inflammatory markers and muscle biopsies are an exploratory outcome. The interventions last eight weeks and combine symptom-titrated exercise therapy, symptom management and education delivered either in a face-to-face setting or through a digital platform ( www.yourcovidrecovery.nhs.uk ). The proposed sample size is 159 participants, and data will be intention-to-treat analyses comparing rehabilitation (face-to-face or digital) to usual care.
Ethics and Dissemination: Ethical approval was gained as part of the PHOSP-COVID study by Yorkshire and the Humber Leeds West Research NHS Ethics Committee, and the study was prospectively registered on the ISRCTN trial registry (ISRCTN13293865). Results will be disseminated to stakeholders, including patients and members of the public, and published in appropriate journals. Strengths and limitations of this study • This protocol utilises two interventions to support those with ongoing symptoms of COVID-19 • This is a two-centre parallel-group randomised controlled trial • The protocol has been supported by patient and public involvement groups who identified treatments of symptoms and activity limitation as a top priority.
(© 2023. The Author(s).)
Databáze: MEDLINE
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