Active — Not RecruitingNot Applicable

Home-based EXercise and motivAtional Program Before and After Liver Transplantation

United Kingdom269 participantsStarted 2022-05-03

Plain-language summary

Liver disease is the 3rd commonest cause of death in adults of working age and liver transplantation (LT) remains the only cure for liver failure. LT exerts a huge stress on the body and mind, especially in people who are already physically and mentally frail because of their liver disease. Investigators know that being physically frailty prior to surgery results in a longer hospital stay because of postoperative complications and contributes to 1 in 10 patients either dying whilst still on the waiting list or shortly after LT. Exercise is one of the most powerful medical therapies available, with numerous proven benefits to patients with diseases like diabetes, heart disease and cancer. Despite this, exercise is not currently used in patients with liver failure or recovering from LT, due to a lack of robust evidence. Exercise may have the potential to improve the lives of people with liver disease and reduce the side-effects of LT surgery. The current standard of care for NHS patients awaiting LT is an advice leaflet. Evidence-based exercise programmes around the time of transplantation do not exist. Only a few small studies have indicated that supervised, hospital-based exercise can improve physical function and quality of life. AIMS: Investigators aim to determine the effect of a home-based exercise and motivation-support programme in patients undergoing LT on their quality of life after surgery. Investigators would also like to understand if exercise results in improvements in intricate measures of physical fitness and muscle function that account for changes in quality of life, and how the motivation-support component of the intervention enhances uptake and ongoing engagement of exercise pre and post LT.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (aged 18 years or over) * Patients listed for a cadaveric, primary LT at QEUHB or the RFH * Being an out-patient at the time of baseline trial visit (consent) Exclusion Criteria: Patients listed for LT for any of the following reasons: * super-urgent LT (according to the Kings College criteria) * multi-organ transplantation (e.g. combined liver and kidney transplant) * live-related donor LT * re-graft LT Patients with an inability to safely comply with the exercise intervention due to: * severe hepatic encephalopathy (grade 3 or 4; or as judged by the clinical investigators) * oxygen-dependent hepato-pulmonary syndrome Patients without liver failure, including: * liver cancer in the absence of cirrhosis * polycystic liver disease * rare metabolic/genetic conditions (e.g. glycogen storage disorders) Refusal or lacks capacity to give informed consent to participate in the trial, at the point of study visit 1 (baseline)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The physical component score (PCS) from the short form-36 version 2.0 (SF-36v2) health-related Quality of Life questionnaire

Timeframe: Baseline (visit 1, week 0) up to 24 weeks post-LT

Trial details

NCT IDNCT07063940

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

View on ClinicalTrials.gov More Liver Transplant Surgery trials