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Randomized Controlled Trial
. 2022 Aug 15;23(1):660.
doi: 10.1186/s13063-022-06632-y.

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 #  1 , Stuart R Gray #  1 , H K Bayes  2 , R Sykes  1 , E McGarry  2 , D Anderson  2 , D Boiskin  3 , C Burke  3 , J G F Cleland  4 , C Goodyear  5 , T Ibbotson  6 , C C Lang  7 , McConnachie  4 , F Mair  6 , K Mangion  1 , M Patel  8 , N Sattar  1 , D Taggart  9 , R Taylor  6 , S Dawkes  10 , C Berry  11
Affiliations
Randomized Controlled Trial

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 et al. Trials. .

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.

Keywords: COVID-19; Long COVID; Randomised controlled trial; Rehabilitation; Resistance exercise; SARS-CoV-2.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram
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References

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