Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study.

Frailty is associated with increased mortality both before and after liver transplantation (LT). There are no standardized exercise programs, in particular home-based exercise programs (HBEPs), for patients awaiting LT. The aim was to investigate the feasibility of such a program in patients awaiting LT. Patients were randomly selected from the Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises. Feasibility was based on patient eligibility (≥66% of waiting list), target recruitment (≥90% of n = 20), safety (no related serious adverse events), and adherence (≥66% adherence to 6-week HBEP). Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS]) were taken at baseline and at 6 and 12 weeks. 18 patients (50% male; median age, 55 years) were recruited. All domains of the study feasibility criteria were met. ISWT improved after 6 weeks (50 m; P ≤ 0.01) and 12 weeks (210 m; P ≤ 0.01), despite withdrawal of the telephone health calls. Similarly, improvements were seen in ADS (2700/day; P ≤ 0.01) and the SPPBT (2.5; P = 0.02) after 12 weeks. There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04). In conclusion, a 12-week HBEP, incorporating both easy-to-apply resistance and aerobic exercises, is safe and feasible in patients awaiting LT. Measures of aerobic and functional capacity demonstrate trends toward improvement that warrant further investigation in a randomized controlled trial.

Home-based exercise in patients with refractory fatigue associated with primary biliary cholangitis: a protocol for the EXerCise Intervention in cholesTatic LivEr Disease (EXCITED) feasibility trial.

INTRODUCTION: Fatigue is the most commonly reported symptom of the liver disease primary biliary cholangitis (PBC). It affects 40%-80% of patients, has no effective treatment and is associated with heightened mortality risk. The pathogenesis is unknown, but muscle bioenergetic abnormalities have been proposed to contribute. Directly observed exercise has been shown to attenuate symptoms in small groups; however, due to the rare nature of the disease, home-based interventions need to be evaluated for feasibility, safety and efficacy. METHODS AND ANALYSIS: This is a phase 1/pilot, single-arm, open-label clinical trial evaluating a novel home-based exercise programme in patients with PBC with severe fatigue. Forty patients with moderate-severe fatigue (PBC40 fatigue domain score >33; other causes of fatigue excluded) will be selected using a convenience sampling method. A 12-week home-based exercise programme, consisting of individualised resistance, aerobic exercises and telephone health calls (first 6 weeks only), will be delivered. Measures of fatigue (PBC40 fatigue domain; fatigue impact scale), quality of life, sleep (Epworth Sleep Score), physical activity, anxiety and depression, aerobic exercise capacity (incremental shuttle walk test; Duke Activity Status Index) and functional capacity (short physical performance battery) will be assessed at baseline and at 6 and 12 weeks following the intervention. ETHICS AND DISSEMINATION: The protocol is approved by the National Research Ethics Service Committee London (IRAS 253115). Recruitment commenced in April 2019 and ended in March 2020. Participant follow-up is due to finish by December 2020. Findings will be disseminated through peer-reviewed publication, conference presentation and social media. TRIAL REGISTRATION NUMBER: NCT04265235.

Home-based exercise therapy in patients awaiting liver transplantation: protocol for an observational feasibility trial.

INTRODUCTION: Liver disease is the third most common cause of premature mortality in the UK. Liver failure accelerates frailty, resulting in skeletal muscle atrophy, functional decline and an associated risk of liver transplant waiting list mortality. However, there is limited research investigating the impact of exercise on patient outcomes pre and post liver transplantation. The waitlist period for patients listed for liver transplantation provides a unique opportunity to provide and assess interventions such as prehabilitation. METHODS AND ANALYSIS: This study is a phase I observational study evaluating the feasibility of conducting a randomised control trial (RCT) investigating the use of a home-based exercise programme (HBEP) in the management of patients awaiting liver transplantation. Twenty eligible patients will be randomly selected from the Queen Elizabeth University Hospital Birmingham liver transplant waiting list. Participants will be provided with an individually tailored 12-week HBEP, including step targets and resistance exercises. Activity trackers and patient diaries will be provided to support data collection. For the initial 6 weeks, telephone support will be given to discuss compliance with the study intervention, achievement of weekly targets, and to address any queries or concerns regarding the intervention. During weeks 6-12, participants will continue the intervention without telephone support to evaluate longer term adherence to the study intervention. On completing the intervention, all participants will be invited to engage in a focus group to discuss their experiences and the feasibility of an RCT. ETHICS AND DISSEMINATION: The protocol is approved by the National Research Ethics Service Committee North West - Greater Manchester East and Health Research Authority (REC reference: 17/NW/0120). Recruitment into the study started in April 2017 and ended in July 2017. Follow-up of participants is ongoing and due to finish by the end of 2017. The findings of this study will be disseminated through peer-reviewed publications and international presentations. In addition, the protocol will be placed on the British Liver Trust website for public access. TRIAL REGISTRATION NUMBER: NCT02949505; Pre-results.