Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT): study protocol for phase II two-centre, randomised controlled trial

Abstract

Introduction: Physical frailty is associated with increased mortality and poor quality of life (QoL) before and after liver transplantation (LT). Evidence is lacking on how to tailor exercise and behavioural techniques in this patient population.

Methods and analysis: Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT) is a phase 2b, open-label, two-centre randomised controlled clinical trial designed to investigate whether a remotely monitored 'home-based exercise and theory-based motivation support programme (HBEP)' before and after LT improves QoL in LT recipients. Adult patients awaiting a primary LT will be assessed for eligibility at two LT centres (Birmingham, Royal Free London). Participants will be randomly assigned (1:1) to receive either an HBEP while on the LT waiting list through to 24 weeks after LT (Intervention) or a patient exercise advice leaflet (Control). Using a standard method of difference in means (two-sided significance level 0.05; power 0.90) and accounting for a 35% attrition/withdrawal rate, a minimum of 133 patients will be randomised to each treatment group. The primary outcome measure will be assessed using intention-to-treat analysis of the difference in the Physical Component Score of Short form-36 version 2.0 health-related QoL questionnaire between the groups at 24 weeks post-LT.

Ethics and dissemination: The protocol was approved by the South Central-Hampshire A National Research Ethics Committee. Recruitment into the EXALT trial started in May 2022 and is due to end in June 2024, with 217/266 patients randomised to date. The intervention follow-up is due to finish in May 2026. The findings of this trial will be disseminated through peer-reviewed publications, conferences and social media.

Trial registration number: ISRCTN13476586.

Keywords: CIRRHOSIS; LIVER FAILURE; LIVER TRANSPLANTATION; PSYCHOLOGY; QUALITY OF LIFE.

Figure 1. EXALT trial design schematic. *At baseline, at 6 weeks (pretransplant) and 24 weeks after transplant (mechanistic ‘muscle’ substudy; n=100; optional): Cardiopulmonary exercise tests, muscle ultrasound and biomarkers. CCI, Comprehensive Complications Index; EXALT, EXercise and motivAtional programme before and after Liver Transplantation; PCS, Physical Component Score; RFH, Royal Free Hospital; SF-36, Short form-36; QEUHB, Queen Elizabeth University Hospital Birmingham.** represents Key Secondary Outcome.

Figure 2. The programme and entry level of HBEP. (A) The initial level (duration, recovery period, intensity) of aerobic exercise sessions was determined from the baseline DASI. (B) The resistance exercise sessions will be developed according to the LFI.