This feasibility RCT demonstrates that a Phase III RCT of prehabilitation versus usual care may be feasible in living liver donors, with no intervention-related adverse events and adherence ≥75% across each component of the prehabilitation program.
Key Findings
Results
The recruitment rate for the feasibility RCT was 48%, with 30 of 63 eligible patients enrolled.
63 patients were deemed eligible at Toronto General Hospital
30 patients were enrolled, yielding a 48% enrollment rate
Participants were randomized 2:1 to prehabilitation or usual care
Mean age of participants was 42 ± 8 years and 67% were female
Results
There were no intervention-related adverse events in the prehabilitation group.
Safety was assessed as part of the primary feasibility outcome
Adverse event monitoring was conducted across all components of the multimodal prehabilitation intervention
The four components included exercise, nutrition support, psychological counselling, and peer mentor sessions
Results
Attrition in the study was 33%.
Retention was assessed as one of the primary feasibility outcomes alongside recruitment, adverse events, adherence, and healthcare provider engagement
Attrition rate of 33% was observed across the study population
Retention was measured from enrollment through postoperative follow-up at 4 and 12 weeks
Results
Adherence to each component of the multimodal prehabilitation intervention was at least 75%.
Adherence was ≥75% across each of the four components: exercise, nutrition support, psychological counselling, and peer mentor sessions
Adherence was measured as part of the primary feasibility outcome
Clinical, patient-reported, and physical fitness outcomes were collected at baseline, preoperatively, and at 4 and 12 weeks postoperatively
Results
Qualitative interviews demonstrated participant satisfaction with the prehabilitation intervention and identified areas for improvement for a Phase III RCT.
Qualitative interviews were used to assess feasibility and satisfaction with the intervention
Interviews revealed both satisfaction with the current prehabilitation program and areas for improvement
Healthcare provider engagement was also assessed as part of the primary feasibility outcome
Findings from interviews will inform the design of the Phase III RCT
Background
No prior study had examined the role of multimodal prehabilitation for living donor liver transplantation prior to this trial.
The authors identified a gap in the literature regarding prehabilitation specifically for living liver donors (LLDs)
Preserving health and quality of life are stated priorities of care for LLDs due to their altruistic contribution
A feasibility study was identified as necessary prior to determining efficacy of prehabilitation in this population
Methods
The multimodal prehabilitation intervention comprised four components: exercise, nutrition support, psychological counselling, and peer mentor sessions.
The peer mentor component specifically involved living liver donor peer mentor sessions
Outcomes were collected at baseline, preoperatively, and at 4 and 12 weeks postoperatively
The intervention was compared against usual care in a randomized 2:1 allocation
The study was conducted at Toronto General Hospital and registered as NCT0543136
Sibley D, Clarke H, Randall I, Au D, Brahmbhatt P, Selzner N, et al.. (2026). PRehab tO PreparE Living Liver Donors for Enhanced Recovery (PROPELLER): A Feasibility Randomized Controlled Trial.. Clinical transplantation. https://doi.org/10.1111/ctr.70490