The effectiveness and acceptability of face-to-face rehabilitation for patients with Long Covid who were not hospitalised with their acute infection: a mixed-methods study comprising a randomised controlled trial RCT with embedded qualitative component
BACKGROUND
Long Covid is a term used to describe a multisystem condition that presents with a myriad of physical and psychological symptoms that continue or develop after acute COVID-19. Long Covid is a significant public health problem because of the nature of the illness, its negative impfact on everyday functioning, and the healthcare inequalities evident in access and experience, notably in terms of ethnicity and socioeconomic status. Evidence in patients hospitalised with their acute infection suggests exercise-based rehabilitation could be helpful to improve exercise tolerance, respiratory symptoms, fatigue, and cognition; however, research is needed to determine whether exercise-based rehabilitation is effective and acceptable for patients with Long Covid who were not hospitalised.
METHODS
This mixed-methods study comprises a single-centre, randomised controlled trial to determine whether face-to-face rehabilitation increases exercise capacity compared to usual care alone in non-hospitalised patients with Long Covid, with embedded qualitative components to explore intervention acceptability in the context of healthcare inequalities. Usual care is as defined by the National Institute for Clinical Excellence (NICE) Covid-19 guidance. The rehabilitation intervention will take place twice a week for 6 weeks and will combine symptom-titrated exercise with self-management education. The proposed sample size of 56 for the randomised controlled trial is calculated on the primary outcome of Incremental Shuttle Walking Test (ISWT) distance, with a change of 50metres (m) at 90% power, a standard deviation of 17 m, and a 0.05 type 1 error.
DISCUSSION
A mixed-methods approach has been chosen as quantitative data alone would be insufficient to answer the research question, and mixing the data will enable a more comprehensive understanding and ensure there is an equal focus on outcomes and experiences of a face-to-face exercise-based rehabilitation programme. A healthcare inequalities lens will explore who may be under-represented, with the qualitative work providing further evidence as to why this may be the case. It is recognised that meeting recruitment targets in the context of reducing referral rates and funding for Long Covid services may prove challenging. Trial registration ISRCTN trial registry (ISRCTN33340595). Registered on 30 September 2024.
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Kontou, Kate; Daynes, Enya; Singh, Sally J; Evans, Rachael A; Gardiner, Nikki; Chaplin, Emma; Richardson, Matthew; Bishop, Nicolette; Creese, Jennifer; Bateman, Nicola; Wright, Adam; Zivtins, Elga; Houchen-Wolloff, Linzy
BACKGROUND
Long Covid is a term used to describe a multisystem condition that presents with a myriad of physical and psychological symptoms that continue or develop after acute COVID-19. Long Covid is a significant public health problem because of the nature of the illness, its negative impfact on everyday functioning, and the healthcare inequalities evident in access and experience, notably in terms of ethnicity and socioeconomic status. Evidence in patients hospitalised with their acute infection suggests exercise-based rehabilitation could be helpful to improve exercise tolerance, respiratory symptoms, fatigue, and cognition; however, research is needed to determine whether exercise-based rehabilitation is effective and acceptable for patients with Long Covid who were not hospitalised.
METHODS
This mixed-methods study comprises a single-centre, randomised controlled trial to determine whether face-to-face rehabilitation increases exercise capacity compared to usual care alone in non-hospitalised patients with Long Covid, with embedded qualitative components to explore intervention acceptability in the context of healthcare inequalities. Usual care is as defined by the National Institute for Clinical Excellence (NICE) Covid-19 guidance. The rehabilitation intervention will take place twice a week for 6 weeks and will combine symptom-titrated exercise with self-management education. The proposed sample size of 56 for the randomised controlled trial is calculated on the primary outcome of Incremental Shuttle Walking Test (ISWT) distance, with a change of 50metres (m) at 90% power, a standard deviation of 17 m, and a 0.05 type 1 error.
DISCUSSION
A mixed-methods approach has been chosen as quantitative data alone would be insufficient to answer the research question, and mixing the data will enable a more comprehensive understanding and ensure there is an equal focus on outcomes and experiences of a face-to-face exercise-based rehabilitation programme. A healthcare inequalities lens will explore who may be under-represented, with the qualitative work providing further evidence as to why this may be the case. It is recognised that meeting recruitment targets in the context of reducing referral rates and funding for Long Covid services may prove challenging. Trial registration ISRCTN trial registry (ISRCTN33340595). Registered on 30 September 2024.
Web | DOI | PDF | Trials | Open Access
