Skip to main content
Top
Published in: Trials 1/2022

Open Access 01-12-2022 | Long-COVID Syndrome | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2022

Login to get access

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
Appendix
Available only for authorised users
Literature
1.
go back to reference Ball S, Banerjee A, Berry C, Boyle JR, Bray B, Bradlow W, et al. Monitoring indirect impact of COVID-19 pandemic on services for cardiovascular diseases in the UK. Heart. 2020;106:1890–7.CrossRef Ball S, Banerjee A, Berry C, Boyle JR, Bray B, Bradlow W, et al. Monitoring indirect impact of COVID-19 pandemic on services for cardiovascular diseases in the UK. Heart. 2020;106:1890–7.CrossRef
2.
go back to reference Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, et al. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020;369:m1985.CrossRef Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, et al. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020;369:m1985.CrossRef
3.
go back to reference Sattar N, Ho FK, Gill JMR, Ghouri N, Gray SR, Celis-Morales CA, et al. BMI and future risk for COVID-19 infection and death across sex, age and ethnicity: preliminary findings from UK biobank. Diabetes Metab Syndr. 2020;14:1149–51 Cold Spring Harbor Laboratory Press.CrossRef Sattar N, Ho FK, Gill JMR, Ghouri N, Gray SR, Celis-Morales CA, et al. BMI and future risk for COVID-19 infection and death across sex, age and ethnicity: preliminary findings from UK biobank. Diabetes Metab Syndr. 2020;14:1149–51 Cold Spring Harbor Laboratory Press.CrossRef
4.
go back to reference Libby P, Lüscher T. COVID-19 is, in the end, an endothelial disease. Eur Heart J. 2020;41:3038–44.CrossRef Libby P, Lüscher T. COVID-19 is, in the end, an endothelial disease. Eur Heart J. 2020;41:3038–44.CrossRef
5.
go back to reference Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, et al. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020;116:1666–87.CrossRef Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, et al. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020;116:1666–87.CrossRef
8.
go back to reference Dweck MR, Bularga A, Hahn RT, Bing R, Lee KK, Chapman AR, et al. Global evaluation of echocardiography in patients with COVID-19. Eur Heart J Cardiovasc Imaging. 2020;21:949–58.CrossRef Dweck MR, Bularga A, Hahn RT, Bing R, Lee KK, Chapman AR, et al. Global evaluation of echocardiography in patients with COVID-19. Eur Heart J Cardiovasc Imaging. 2020;21:949–58.CrossRef
9.
go back to reference Gualtieri P, Falcone C, Romano L, Macheda S, Correale P, Arciello P, et al. Body composition findings by computed tomography in SARS-CoV-2 patients: increased risk of muscle wasting in obesity. Int J Mol Sci. 2020;21:4670 MDPI.CrossRef Gualtieri P, Falcone C, Romano L, Macheda S, Correale P, Arciello P, et al. Body composition findings by computed tomography in SARS-CoV-2 patients: increased risk of muscle wasting in obesity. Int J Mol Sci. 2020;21:4670 MDPI.CrossRef
10.
go back to reference Morley JE, Kalantar-Zadeh K, Anker SD. COVID-19: a major cause of cachexia and sarcopenia? J Cachexia Sarcopenia Muscle. 2020;11(4):863–5.CrossRef Morley JE, Kalantar-Zadeh K, Anker SD. COVID-19: a major cause of cachexia and sarcopenia? J Cachexia Sarcopenia Muscle. 2020;11(4):863–5.CrossRef
11.
go back to reference Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, et al. Two weeks of reduced activity decreases leg lean mass and induces “anabolic resistance” of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013;98:2604–12.CrossRef Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, et al. Two weeks of reduced activity decreases leg lean mass and induces “anabolic resistance” of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013;98:2604–12.CrossRef
12.
go back to reference Olsen RH, Krogh-Madsen R, Thomsen C, Booth FW, Pedersen B. Metabolic responses to reduced daily steps. JAMA Lett. 2008;299(11):1261-3. Olsen RH, Krogh-Madsen R, Thomsen C, Booth FW, Pedersen B. Metabolic responses to reduced daily steps. JAMA Lett. 2008;299(11):1261-3.
13.
go back to reference Rooney S, Webster A, Paul L. Systematic review of changes and recovery in physical function and fitness after severe acute respiratory syndrome-related coronavirus infection: implications for COVID-19 rehabilitation. Phys Ther. 2020;100:1717–29.CrossRef Rooney S, Webster A, Paul L. Systematic review of changes and recovery in physical function and fitness after severe acute respiratory syndrome-related coronavirus infection: implications for COVID-19 rehabilitation. Phys Ther. 2020;100:1717–29.CrossRef
14.
go back to reference Pan B, Ge L, Xun YQ, Chen YJ, Gao CY, Han X, et al. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis. Int J Behav Nutr Phys Act. 2018;15:1–14.CrossRef Pan B, Ge L, Xun YQ, Chen YJ, Gao CY, Han X, et al. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis. Int J Behav Nutr Phys Act. 2018;15:1–14.CrossRef
15.
go back to reference Ashton RE, Tew GA, Aning JJ, Gilbert SE, Lewis L, Saxton JM. Effects of short-term, medium-term and long-term resistance exercise training on cardiometabolic health outcomes in adults: systematic review with meta-analysis. Br J Sports Med. 2020;54(6):341-8. Ashton RE, Tew GA, Aning JJ, Gilbert SE, Lewis L, Saxton JM. Effects of short-term, medium-term and long-term resistance exercise training on cardiometabolic health outcomes in adults: systematic review with meta-analysis. Br J Sports Med. 2020;54(6):341-8.
17.
go back to reference Devries MC, Breen L, von Allmen M, MacDonald MJ, Moore DR, Offord EA, et al. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015;3:1–13.CrossRef Devries MC, Breen L, von Allmen M, MacDonald MJ, Moore DR, Offord EA, et al. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015;3:1–13.CrossRef
19.
go back to reference Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, et al. Attributes and predictors of long COVID. Nat Med. 2021;27:626–31.CrossRef Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, et al. Attributes and predictors of long COVID. Nat Med. 2021;27:626–31.CrossRef
20.
go back to reference Robertson RJ, Goss FL, Rutkowski J, Lenz B, Dixon C, Timmer J, et al. Concurrent validation of the OMNI perceived exertion scale for resistance exercise. Med Sci Sports Exerc. 2003;35:333–41 United States.CrossRef Robertson RJ, Goss FL, Rutkowski J, Lenz B, Dixon C, Timmer J, et al. Concurrent validation of the OMNI perceived exertion scale for resistance exercise. Med Sci Sports Exerc. 2003;35:333–41 United States.CrossRef
22.
go back to reference Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49:M85–94 United States.CrossRef Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49:M85–94 United States.CrossRef
27.
go back to reference Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95 United States.CrossRef Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95 United States.CrossRef
34.
go back to reference Daynes E, Gerlis C, Chaplin E, Gardiner N, Singh SJ. Early experiences of rehabilitation for individuals post-COVID to improve fatigue, breathlessness exercise capacity and cognition – a cohort study. Chron Respir Dis. 2021;18:14799731211015692. https://doi.org/10.1177/14799731211015691 SAGE Publications Ltd STM.CrossRef Daynes E, Gerlis C, Chaplin E, Gardiner N, Singh SJ. Early experiences of rehabilitation for individuals post-COVID to improve fatigue, breathlessness exercise capacity and cognition – a cohort study. Chron Respir Dis. 2021;18:14799731211015692. https://​doi.​org/​10.​1177/​1479973121101569​1 SAGE Publications Ltd STM.CrossRef
Metadata
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
Authors
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
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06632-y

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue