Contemporary clinical trials · 2026
Protocol for OPAL: Online prehabilitation for patients with cirrhosis awaiting liver transplantation - A multicentre randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Cruz Christofer, Mak Carly, Selzner Nazia, Brahmania Mayur, Marquez Vladimir, Khan Mohammad Qasim, Benmassaoud Amine, Velazquez Carlos Moctezuma, Niazi Mina, Bémeur Chantal, Hogue Crystèle, Gillis Chelsia, Alemayehu Wendimagegn, Hyde Ashley, Quintanilha Maira, Ezekowitz Justin, Spence John C, Ismond Kathleen, Rose Christopher F, Prado Carla M, McNeely Margaret L, Tandon Puneeta, all OPAL study investigators
Аннотация
BACKGROUND: Frailty is common in patients with cirrhosis awaiting liver transplantation (LT) and is associated with poor health outcomes. Prehabilitation trials in patients with cirrhosis awaiting LT have been limited by pilot designs, small sample sizes, single-centre trials, low adherence, and lack of fully multidomain interventions (exercise, nutrition, and psychological components). Online delivery may enhance scalability and accessibility, particularly in a geographically dispersed healthcare system like Canada. However, the effectiveness and acceptability of a centrally delivered, online multidomain prehabilitation program across multiple LT centres has not been studied.
METHODS: Compared to a control group, this randomized controlled trial will assess the effectiveness of a multidomain online prehabilitation program (OPAL) for up to 12 weeks across 6 LT programs. Inclusion criteria are adults with cirrhosis awaiting LT, are pre-frail or frail on a liver frailty index, have English or French language proficiency and own an internet-connected device. Recruited participants will be randomized 2:1 to prehabilitation or control. The primary endpoint is change in physical function measured by the five times sit-to-stand test at 12 weeks or last timepoint before transplant. Secondary outcomes include frailty, other physical function tests, quality of life, and participant acceptability. Exploratory outcomes include covert hepatic encephalopathy, muscle mass, malnutrition, behavioural factors, adherence, and clinical health outcomes.
CONCLUSION: This multi-centre, online, multidomain prehabilitation program for patients with cirrhosis awaiting LT will evaluate the effectiveness and acceptability of digitally delivered prehabilitation. Learnings will inform the future design and implementation of scalable interventions to support patients during the pre-LT period.
METHODS: Compared to a control group, this randomized controlled trial will assess the effectiveness of a multidomain online prehabilitation program (OPAL) for up to 12 weeks across 6 LT programs. Inclusion criteria are adults with cirrhosis awaiting LT, are pre-frail or frail on a liver frailty index, have English or French language proficiency and own an internet-connected device. Recruited participants will be randomized 2:1 to prehabilitation or control. The primary endpoint is change in physical function measured by the five times sit-to-stand test at 12 weeks or last timepoint before transplant. Secondary outcomes include frailty, other physical function tests, quality of life, and participant acceptability. Exploratory outcomes include covert hepatic encephalopathy, muscle mass, malnutrition, behavioural factors, adherence, and clinical health outcomes.
CONCLUSION: This multi-centre, online, multidomain prehabilitation program for patients with cirrhosis awaiting LT will evaluate the effectiveness and acceptability of digitally delivered prehabilitation. Learnings will inform the future design and implementation of scalable interventions to support patients during the pre-LT period.