PRehab tO PreparE Living Liver Donors for Enhanced Recovery (PROPELLER): A Feasibility Randomized Controlled Trial

Preserving health and quality of life are priorities of care for living liver donors (LLDs) due to their altruistic contribution to recipients. No study has examined the role of multimodal prehabilitation for living donor liver transplantation (LDLT). Prior to determining the efficacy of prehabilitation in LLDs, a feasibility study is required.

The objective of this feasibility randomized controlled trial (RCT) was to assess the feasibility of conducting a large-scale RCT of prehabilitation prior to LDLT. Thirty LLDs at Toronto General Hospital were randomized 2:1 to receive multimodal prehabilitation or usual care, respectively. The prehabilitation intervention comprised: (1) exercise, (2) nutrition support, (3) psychological counselling, and (4) LLD peer mentor sessions. The primary outcome was feasibility via rates of recruitment, retention, adverse events, adherence, and healthcare provider engagement. Clinical, patient-reported, and physical fitness outcomes were collected at baseline, preoperatively, and at 4 and 12 weeks postoperatively. Qualitative interviews were used to assess feasibility and satisfaction with the intervention.

Sixty-three patients were eligible and 30 enrolled (48%). Participants' mean age was 42 ± 8 and 67% were female. There were no intervention-related adverse events. Attrition was 33% and adherence across each of the components of prehabilitation was ≥75%. Interviews demonstrated satisfaction with the prehabilitation intervention and areas for improvement for a Phase III RCT.

This study demonstrates a Phase III RCT of prehabilitation versus usual care may be feasible in LLDs. The Phase III trial will confirm the preliminary and exploratory physical and psychosocial benefit reported in this study.

ClinicalTrials.gov identifier: NCT0543136.