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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

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posted on 2023-02-16, 15:18 authored by Enya Daynes, Molly Baldwin, Neil J. Greening, Thomas Yates, Nicolette BishopNicolette Bishop, George Mills, Matthew RobertsMatthew Roberts, Malik HamrouniMalik Hamrouni, Tatiana Plekhanova, Ioannis Vogiatzis, Carlos Echevarria, Rashmita Nathu, Hamish J. C. McAuley, Lorna Latimer, Jennifer Glennie, Francesca Chambers, Ruth Penfold, Emily Hume, Dimitrios Megaritis, Charikleia Alexiou, Sebastian Potthoff, Mitchell James Hogg, Catherine Haighton, Bethany Nichol, Olivia C. Leavy, Matthew Richardson, Omer Elneima, Amisha Singapuri, Marco Sereno, Ruth M. Saunders, Victoria C. Harris, Claire M. Nolan, Charlotte Bolton, Linzy Houchen-Wolloff, Ewen M. Harrison, Nazir Lone, Jennifer Quint, James D. Chalmers, Ling-Pei Ho, Alex Horsley, Michael Marks, Krisnah Poinasamy, Betty Ramen, Louise V. Wain, Christopher Brightling, William D.-C. Man, Rachael Evans, Sally J. Singh

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. 

Article summary

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

Funding

PHOSP-COVID Post-hospitalisation COVID-19 study: a national consortium to understand and improve long-term health outcomes

Medical Research Council

Find out more...

UK Research and Innovation and National Institute of Health Research (grant reference COV0319)

NIHR Leicester Biomedical Research Centre

Northumbria University Newcastle (MDRT IHSC and HLS Faculty)

History

School

  • Sport, Exercise and Health Sciences

Published in

Trials

Volume

24

Issue

1

Publisher

BMC

Version

  • VoR (Version of Record)

Rights holder

© The Author(s)

Publisher statement

This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Acceptance date

2023-01-11

Publication date

2023-01-26

Copyright date

2023

Notes

Following publication of the original article [1], it was noticed that the author name Dimitrios Megaritis was incorrectly written as Dimitrios Magaritis. The author group has been updated above and the original article has been corrected.

eISSN

1745-6215

Language

  • en

Depositor

Prof Lettie Bishop. Deposit date: 14 February 2023

Article number

61

Ethics review number

20/YH/0225