Trials (Aug 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

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

DOI
https://doi.org/10.1186/s13063-022-06632-y
Journal volume & issue
Vol. 23, no. 1
pp. 1 – 13

Abstract

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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

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