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. and Gray, Stuart R. and Bayes, H. K. and Sykes, R. and McGarry, E. and Anderson, D. and Boiskin, D. and Burke, C. and Cleland, J. G.F. and Goodyear, C. and Ibbotson, T. and Lang, C. C. and McConnachie and Mair, F. and Mangion, K. and Patel, M. and Sattar, N. and Taggart, D. and Taylor, R. and Dawkes, S. and Berry, C. (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, 23 (1). 660. ISSN 1745-6215 (https://doi.org/10.1186/s13063-022-06632-y)

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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.

CORE (COnnecting REpositories)