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Online Prehabilitation for Patients Awaiting Liver Transplantation

RecruitingNAAges 18 Years - anyAllUniversity of Alberta
NCT05899231 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Physical frailty is common in patients awaiting liver transplantation and has been associated with poor health outcomes. There is promising data from small studies showing that behavioural, nutrition, exercise therapy (prehabilitation) improves physical function in patients while they are waiting for a liver transplant. The proposed trial will assess if a 12-week online prehabilitation program improves physical function in patients listed for liver transplantation. Over 4 years, 177 patients will be recruited from 6 transplant centres across Canada and will be randomized to receive either the online prehabilitation program or usual care. The primary outcome of physical function will be evaluated using the FTSST at baseline and 12 weeks (or last timepoint before transplant) assessed virtually or in-person. Secondary outcomes include liver specific physical frailty, aerobic fitness, heal

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📋 Eligibility rules (as published)
Inclusion Criteria: ≥18 years old with cirrhosis (confirmed with transient elastography by FibroScan, histology, or imaging-based assessment with compatible clinical picture), referred for transplant and are assessed to have a high likelihood of being listed according to a preliminary review by hepatologist or are already listed for LT, are pre-frail or frail on the liver frailty index (LFI) or (added August 30, 2024) pre-frail or frail on the TeLeFI (prefrail LFI 3.2-4.3 and frail LFI ≥4.4), have English or French language proficiency, and own an internet-connected device. Exclusion Criteria: * Listed for living related donor transplantation with expected time on the wait list \<12 weeks, or model for end-stage liver disease (MELD-Na) Score \>26 (Justification: time to transplant is very short) * Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit) * Unable to provide informed consent * Presence of a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation * Life expectancy less than 6 months, compassionate care (clinician judgment) (Justification: unlikely to see benefit) * Recent variceal bleed or history of varices not on adequate prophylaxis (Justification: acute exercise increases portal pressure * Transplant indication is cholangiocarcinoma.
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What it tests

  • Prehabilitation Programming
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Where

6 sites
Foothills Medical Centre
Calgary, Canada
Kaye Edmonton Clinic
Edmonton, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, Canada
London Health Sciences Centre
London, Canada
Toronto General Hospital - Ajmera Transplant Centre
Toronto, Canada
McGill University Health Centre
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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