Every year, over 1,000 people in the UK receive a liver transplant, but many are so frail from chronic liver disease that they struggle to recover, facing higher risks of complications and poor quality of life. This trial tests whether a home-based exercise and motivation programme, delivered before and after transplant, can change that. The problem is clear: patients with liver failure often have physical barriers like muscle wasting and fatigue, plus mental barriers like anxiety and lack of motivation. Existing advice leaflets are not enough. The researchers will recruit 266 patients across two centres, randomly assigning half to a remotely monitored, individualised exercise and behavioural support programme, and half to standard advice leaflets. The primary measure is physical quality of life six months after transplant. If the programme works, it could reduce hospital stays, cut surgical complications, and help patients return to work faster. That would deliver both clinical and economic benefits, making liver transplantation more efficient and improving daily life for a growing patient population.
View original technical description
Background: Chronic liver disease is the 3rd commonest cause of death in the UK and liver transplantation (LT) remains the only cure, with over 1000/year performed. LT exerts a huge physiological/psychological stress on patients, who are physically and mentally frail as a consequence of liver disease. Frailty is associated with increased morbidity, mortality and poor quality of life (QoL), both before and after LT. The efficacy and safety of exercise interventions and their tolerability to patients with liver failure or those recovering from LT remains poorly understood. There are notable physical and mental barriers to exercise therapy in patients with liver disease, including the presence of ascites, encephalopathy, sarcopenia and fatigue, as well as anxiety and a lack of motivation. Evidence is lacking on how to tailor and dose exercise and behavioural techniques to this unique patient population. Main research question: Does a home-based exercise and theory-based motivation support programme delivered before and after LT improve QoL in LT recipients compared to a control group using patient advice leaflets? The study includes two mechanistic questions: (a) What is the mode-of action and dose-effect of the exercise intervention on physical fitness and muscle biology? (b) how does theory-based motivation affect adherence to and engagement with the exercise programme? Study design: A two-centre randomised controlled clinical trial. Primary outcome measure: Physical component summary (PCS) score from the SF-36v2 health-related QoL questionnaire at 6-months post LT. Secondary outcome measures: 1. Comprehensive Complications Index (CCI); 2. Mental component summary score of QoL; 3. Measures of frailty and physical fitness; 4. Adherence to exercise intervention (blinded accelerometer); 5. Pre-LT morbidity/mortality; 5. Post-LT length of ICU/hospital stay, morbidity/mortality (30,90,360-day). Intervention-arm: A remotely monitored, individualised home-based exercise and motivation-support programme undertaken pre-LT (prehabilitation) and for 6-months post-LT (rehabilitation). Control-arm: patient exercise advice leaflet. Study population: Inclusion criteria: Adult patients awaiting a cadaveric LT at home. Exclusion criteria: super-urgent acute LT, multi-organ transplant and/or live-related donor LT; severe hepatic encephalopathy; oxygen-dependent hepato-pulmonary syndrome; patients without liver failure (e.g. polycystic disease). Sample size: 266 patients with 1:1 randomisation. Timelines for delivery: The study duration is 54 months. This includes 6 months for trial set up/staff training, 24 months for recruitment (11/month), 18 months’ intervention, and 6 months follow-up, primary analysis and reporting. Anticipated impact and dissemination: An effective home-based exercise programme that improves objective measures of outcome would have a significant impact on the clinical outcomes and QoL of patients with liver failure undergoing LT. If the intervention can maintain improvements in health and wellbeing and reduce surgical complications it will deliver not only clinical, but economic benefits by reducing hospital admissions, enhancing the efficiency of LT and aiding patients to rapidly return to work. The aim is to publish the findings in high-impact, peer-reviewed medical journals, NIHR Journals Library, NHS Evidence website, present at international conferences and disseminate to patient groups so that they can drive change
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know