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; A. McConnachie; F. Mair; K. Mangion; M. Patel; N. Sattar; D. Taggart; R. Taylor; S. Dawkes; C. Berry

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, 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, A. McConnachie, F. Mair, K. Mangion, M. Patel, N. Sattar, D. Taggart, R. Taylor, S. DawkesC. Berry (Lead / Corresponding author)

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	660
Number of pages	13
Journal	Trials
Volume	23
DOIs	https://doi.org/10.1186/s13063-022-06632-y
Publication status	Published - 15 Aug 2022

Keywords

Adult
COVID-19
Fatigue
Humans
Quality of Life
Resistance Training
SARS-CoV-2
State Medicine
Treatment Outcome
Resistance exercise
Long COVID
Randomised controlled trial
Rehabilitation

ASJC Scopus subject areas

Pharmacology (medical)
Medicine (miscellaneous)

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10.1186/s13063-022-06632-yLicence: CC BY

Final Published VersionFinal published version, 1.17 MBLicence: CC BY

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Morrow, A., Gray, S. 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, A., Mair, F., Mangion, K., Patel, M., Sattar, N., Taggart, D., Taylor, R., ... 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, Article 660. https://doi.org/10.1186/s13063-022-06632-y

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title = "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",

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 = "Adult, COVID-19, Fatigue, Humans, Quality of Life, Resistance Training, SARS-CoV-2, State Medicine, Treatment Outcome, Resistance exercise, Long COVID, Randomised controlled trial, Rehabilitation",

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

note = "Funding Information: The study is funded by a grant from the Chief Scientist Office Scotland and the University of Glasgow British Heart Foundation Centre of Research Excellence (RE/18/634217) Funding Information: We gratefully acknowledge the research staff who are supporting this project and the participants. We thank the members of the University of Glasgow Long COVID-19 patient and public involvement group. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = aug,

day = "15",

doi = "10.1186/s13063-022-06632-y",

language = "English",

volume = "23",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

}

Morrow, A, Gray, SR, Bayes, HK, Sykes, R, McGarry, E, Anderson, D, Boiskin, D, Burke, C, Cleland, JGF, Goodyear, C, Ibbotson, T, Lang, CC, McConnachie, A, Mair, F, Mangion, K, Patel, M, Sattar, N, Taggart, D, Taylor, R, Dawkes, S & 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, vol. 23, 660. https://doi.org/10.1186/s13063-022-06632-y

TY - JOUR

T1 - Prevention and early treatment of the long-term physical effects of COVID-19 in adults

T2 - design of a randomised controlled trial of resistance exercise-CISCO-21

AU - Morrow, A.

AU - Gray, Stuart R.

AU - Bayes, H. K.

AU - Sykes, R.

AU - McGarry, E.

AU - Anderson, D.

AU - Boiskin, D.

AU - Burke, C.

AU - Cleland, J. G. F.

AU - Goodyear, C.

AU - Ibbotson, T.

AU - Lang, C. C.

AU - McConnachie, A.

AU - Mair, F.

AU - Mangion, K.

AU - Patel, M.

AU - Sattar, N.

AU - Taggart, D.

AU - Taylor, R.

AU - Dawkes, S.

AU - Berry, C.

N1 - Funding Information: The study is funded by a grant from the Chief Scientist Office Scotland and the University of Glasgow British Heart Foundation Centre of Research Excellence (RE/18/634217) Funding Information: We gratefully acknowledge the research staff who are supporting this project and the participants. We thank the members of the University of Glasgow Long COVID-19 patient and public involvement group. Publisher Copyright: © 2022, The Author(s).

PY - 2022/8/15

Y1 - 2022/8/15

N2 - 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.

AB - 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.

KW - Adult

KW - COVID-19

KW - Fatigue

KW - Humans

KW - Quality of Life

KW - Resistance Training

KW - SARS-CoV-2

KW - State Medicine

KW - Treatment Outcome

KW - Resistance exercise

KW - Long COVID

KW - Randomised controlled trial

KW - Rehabilitation

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U2 - 10.1186/s13063-022-06632-y

DO - 10.1186/s13063-022-06632-y

M3 - Article

C2 - 35971155

SN - 1745-6215

VL - 23

JO - Trials

JF - Trials

M1 - 660

ER -

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

Abstract

Keywords

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