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Online Prehabilitation for Patients Awaiting Liver Transplantation

RECRUITINGN/ASponsored by University of Alberta
Actively Recruiting
PhaseN/A
SponsorUniversity of Alberta
Started2023-07-12
Est. completion2026-03
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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, health-related quality of life (QoL), participant experience and acceptability. Exploratory outcomes include other virtual and in-person physical function measures, covert hepatic encephalopathy (CHE), sarcopenia, malnutrition, adherence, behaviour factors, clinical and post-transplant outcomes. Results will be compared between the intervention and usual care groups.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

Cirrhosis, LiverLiver DiseaseLiver Transplant Surgery

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