Prevention and early treatment of the long-term physical effects of COVID-19 in adults: design of a randomised controlled trial of resistance exercise: CISCO-21.

Morrow, A.; Gray, Stuart R.; Bayes, H.K.; Sykes, R.; McGarry, E.; Anderson, D.; Boiskin, D.; Burke, C.; Cleland, J.G.F.; Goodyear, C.; Ibbotson, T.; Lang, C.C.; McConnachie; Mair, F.; Mangion, K.; Patel, M.; Sattar, N.; Taggart, D.; Taylor, R.; Dawkes, S.; Berry, C.

Abstract

Background: Coronavirus disease-19 (COVID-19) infection causes persistent health problems such as breathlessness, chest pain and fatigue, and therapies for the prevention and early treatment of post-COVID-19 syndromes are needed. Accordingly, we are investigating the effect of a resistance exercise intervention on exercise capacity and health status following COVID-19 infection. Methods: A two-arm randomised, controlled clinical trial including 220 adults with a diagnosis of COVID-19 in the preceding 6 months. Participants will be classified according to clinical presentation: Group A, not hospitalised due to COVID but persisting symptoms for at least 4 weeks leading to medical review; Group B, discharged after an admission for COVID and with persistent symptoms for at least 4 weeks; or Group C, convalescing in hospital after an admission for COVID. Participants will be randomised to usual care or usual care plus a personalised and pragmatic resistance exercise intervention for 12 weeks. The primary outcome is the incremental shuttle walks test (ISWT) 3 months after randomisation with secondary outcomes including spirometry, grip strength, short performance physical battery (SPPB), frailty status, contacts with healthcare professionals, hospitalisation and questionnaires assessing health-related quality of life, physical activity, fatigue and dyspnoea. Discussion: Ethical approval has been granted by the National Health Service (NHS) West of Scotland Research Ethics Committee (REC) (reference: GN20CA537) and recruitment is ongoing. Trial findings will be disseminated through patient and public forums, scientific conferences and journals. Trial registration: ClinicialTrials.gov NCT04900961. Prospectively registered on 25 May 2021.

Citation

MORROW, A., GRAY, S.R., BAYES, H.K. et al. 2022. Prevention and early treatment of the long-term physical effects of COVID-19 in adults: design of a randomised controlled trial of resistance exercise: CISCO-21. Trials [online], 23, article number 660. Available from: https://doi.org/10.1186/s13063-022-06632-y

• Journal Article Type: Article
• Acceptance Date: Aug 4, 2022
• Online Publication Date: Aug 15, 2022
• Publication Date: Dec 31, 2022
• Deposit Date: Sep 1, 2022
• Publicly Available Date: Sep 1, 2022
• Journal: Trials
• Print ISSN: 1745-6215
• Electronic ISSN: 1745-6215
• Publisher: Springer
• Peer Reviewed: Peer Reviewed
• Volume: 23
• Article Number: 660
• DOI: https://doi.org/10.1186/s13063-022-06632-y
• Keywords: Resistance exercise; Long COVID; SARS-CoV-2; COVID-19; Rehabilitation; Randomised controlled trial
• Public URL: https://rgu-repository.worktribe.com/output/1742021
• PMID: 35971155
• Additional Information: This article has been published with separate supporting information. This supporting information has been incorporated into a single file on this repository and can be found at the end of this document.