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

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • COVID-19 / complications*
  • COVID-19 / therapy
  • Chest Pain
  • Dyspnea
  • Fatigue
  • Humans
  • Post-Acute COVID-19 Syndrome
  • Quality of Life
  • Resistance Training*
  • SARS-CoV-2*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT04900961