Home-based exercise therapy in patients awaiting liver transplantation: protocol for an observational feasibility trial

Felicity Rhian Williams, Alice Vallance, Thomas Faulkner, Jennifer Towey, Derek Kyte, Simon Durman, Jill Johnson, Andrew Holt, M Thamara Perera, James Ferguson, Matthew James Armstrong, Felicity Rhian Williams, Alice Vallance, Thomas Faulkner, Jennifer Towey, Derek Kyte, Simon Durman, Jill Johnson, Andrew Holt, M Thamara Perera, James Ferguson, Matthew James Armstrong

Abstract

Introduction: Liver disease is the third most common cause of premature mortality in the UK. Liver failure accelerates frailty, resulting in skeletal muscle atrophy, functional decline and an associated risk of liver transplant waiting list mortality. However, there is limited research investigating the impact of exercise on patient outcomes pre and post liver transplantation. The waitlist period for patients listed for liver transplantation provides a unique opportunity to provide and assess interventions such as prehabilitation.

Methods and analysis: This study is a phase I observational study evaluating the feasibility of conducting a randomised control trial (RCT) investigating the use of a home-based exercise programme (HBEP) in the management of patients awaiting liver transplantation. Twenty eligible patients will be randomly selected from the Queen Elizabeth University Hospital Birmingham liver transplant waiting list. Participants will be provided with an individually tailored 12-week HBEP, including step targets and resistance exercises. Activity trackers and patient diaries will be provided to support data collection. For the initial 6 weeks, telephone support will be given to discuss compliance with the study intervention, achievement of weekly targets, and to address any queries or concerns regarding the intervention. During weeks 6-12, participants will continue the intervention without telephone support to evaluate longer term adherence to the study intervention. On completing the intervention, all participants will be invited to engage in a focus group to discuss their experiences and the feasibility of an RCT.

Ethics and dissemination: The protocol is approved by the National Research Ethics Service Committee North West - Greater Manchester East and Health Research Authority (REC reference: 17/NW/0120). Recruitment into the study started in April 2017 and ended in July 2017. Follow-up of participants is ongoing and due to finish by the end of 2017. The findings of this study will be disseminated through peer-reviewed publications and international presentations. In addition, the protocol will be placed on the British Liver Trust website for public access.

Trial registration number: NCT02949505; Pre-results.

Keywords: end-stage liver disease; functional capacity; liver transplantation; prehabilitation.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study design overview.
Figure 2
Figure 2
Functional resistance exercises: (A) lunge, (B) rock press, (C) frog squat, (D) bear crawl, (E) side bear crawl and (F) kick sit.

References

    1. Williams R, Aspinall R, Bellis M, et al. . Addressing liver disease in the UK: a blueprint for attaining excellence in health care and reducing premature mortality from lifestyle issues of excess consumption of alcohol, obesity, and viral hepatitis. Lancet 2014;384:1953–97. 10.1016/S0140-6736(14)61838-9
    1. Knaak J, McVey M, Bazerbachi F, et al. . Liver transplantation in patients with end-stage liver disease requiring intensive care unit admission and intubation. Liver Transpl 2015;21:761–7. 10.1002/lt.24115
    1. Fried LP, Tangen CM, Walston J, et al. . Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001;56:M146–M157. 10.1093/gerona/56.3.M146
    1. Lai JC, Dodge JL, Sen S, et al. . Functional decline in patients with cirrhosis awaiting liver transplantation: Results from the functional assessment in liver transplantation (FrAILT) study. Hepatology 2016;63:574–80. 10.1002/hep.28316
    1. Prentis JM, Manas DM, Trenell MI, et al. . Submaximal cardiopulmonary exercise testing predicts 90-day survival after liver transplantation. Liver Transpl 2012;18:152–9. 10.1002/lt.22426
    1. Epstein SK, Freeman RB, Khayat A, et al. . Aerobic capacity is associated with 100-day outcome after hepatic transplantation. Liver Transpl 2004;10:418–24. 10.1002/lt.20088
    1. Dunne DF, Jack S, Jones RP, et al. . Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg 2016;103:504–12. 10.1002/bjs.10096
    1. Li C, Carli F, Lee L, et al. . Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc 2013;27:1072–82. 10.1007/s00464-012-2560-5
    1. Ochmann U, Kotschy-Lang N, Raab W, et al. . Long-term efficacy of pulmonary rehabilitation in patients with occupational respiratory diseases. Respiration 2012;84:396–405. 10.1159/000337271
    1. Smart N, Steele M. Exercise training in haemodialysis patients: a systematic review and meta-analysis. Nephrology 2011;16:626–32. 10.1111/j.1440-1797.2011.01471.x
    1. van der Meer S, Zwerink M, van Brussel M, et al. . Effect of outpatient exercise training programmes in patients with chronic heart failure: a systematic review. Eur J Prev Cardiol 2012;19:795–803. 10.1177/1741826711410516
    1. Department of Health. An outcome strategy for COPD and Asthma: NHS Companion Document [Best Practice Guideline]. 2012. cited 4 Oct 2017.
    1. Williams AM, Waits S, Englesbe MJ. The importance of prehabilitation in liver transplantation. Curr Transplant Rep 2015;2:312–5. 10.1007/s40472-015-0080-7
    1. Román E, García-Galcerán C, Torrades T, et al. . Effects of an exercise programme on functional capacity, body composition and risk of falls in patients with cirrhosis: a randomized clinical trial. PLoS One 2016;11:e0151652 10.1371/journal.pone.0151652
    1. Zenith L, Meena N, Ramadi A, et al. . Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol 2014;12:1920–6. 10.1016/j.cgh.2014.04.016
    1. Garcia AM, Veneroso CE, Soares DD, et al. . Effect of a physical exercise program on the functional capacity of liver transplant patients. Transplant Proc 2014;46:1807–8. 10.1016/j.transproceed.2014.05.023
    1. Debette-Gratien M, Tabouret T, Antonini MT, et al. . Personalized adapted physical activity before liver transplantation: acceptability and results. Transplantation 2015;99:145–50. 10.1097/TP.0000000000000245
    1. Zalewska K. Liver Transplantation: Selection Criteria and Recipient Registration, 2017.
    1. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc 1982;14:377–81. 10.1249/00005768-198205000-00012
    1. Scherr J, Wolfarth B, Christle JW, et al. . Associations between Borg’s rating of perceived exertion and physiological measures of exercise intensity. Eur J Appl Physiol 2013;113:147–55. 10.1007/s00421-012-2421-x
    1. Singh SJ, Morgan MD, Scott S, et al. . Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax 1992;47:1019–24. 10.1136/thx.47.12.1019
    1. Luxton N, Alison JA, Wu J, et al. . Relationship between field walking tests and incremental cycle ergometry in COPD. Respirology 2008;13:856–62. 10.1111/j.1440-1843.2008.01355.x
    1. Fowler SJ, Singh SJ, Revill S. Reproducibility and validity of the incremental shuttle walking test in patients following coronary artery bypass surgery. Physiotherapy 2005;91:22–7. 10.1016/j.physio.2004.08.009
    1. Lee AL, Cecins N, Holland AE, et al. . Field walking tests are reliable and responsive to exercise training in people with non-cystic fibrosis Bronchiectasis. J Cardiopulm Rehabil Prev 2015;35:439–45. 10.1097/HCR.0000000000000130
    1. Struthers R, Erasmus P, Holmes K, et al. . Assessing fitness for surgery: a comparison of questionnaire, incremental shuttle walk, and cardiopulmonary exercise testing in general surgical patients. Br J Anaesth 2008;101:774–80. 10.1093/bja/aen310
    1. Van Reenan M, Janssen B. EQ-5D-5L User Guide: Basic Information on How to Use the EQ-5D-5L Instrument, 2015.
    1. Rothenbacher D, Jaensch A, Mons U, et al. . Prognostic value of one-year course of symptoms of anxiety and depression in patients with coronary heart disease: Role of physical activity and unmet medical need. Eur J Prev Cardiol 2015;22:1129–38. 10.1177/2047487314545317
    1. Bolton CE, Bevan-Smith EF, Blakey JD, et al. . British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax 2013;68(Suppl 2):ii1–30. 10.1136/thoraxjnl-2013-203808
    1. Rehabilitation AoCPiC. Standards for Physical Activity and Exercise in the Cardiovascular Population, 2015. cited 4 Oct 2017.
    1. Murray P, Whiting P, Hutchinson SP, et al. . Preoperative shuttle walking testing and outcome after oesophagogastrectomy. Br J Anaesth 2007;99:809–11. 10.1093/bja/aem305
    1. Care Quality Commission PHEaNI. The NHS Five Years Forward View. NHS England, 2014.

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