NCT07063940

Brief Summary

Liver disease is the 3rd commonest cause of death in adults of working age and liver transplantation (LT) remains the only cure for liver failure. LT exerts a huge stress on the body and mind, especially in people who are already physically and mentally frail because of their liver disease. Investigators know that being physically frailty prior to surgery results in a longer hospital stay because of postoperative complications and contributes to 1 in 10 patients either dying whilst still on the waiting list or shortly after LT. Exercise is one of the most powerful medical therapies available, with numerous proven benefits to patients with diseases like diabetes, heart disease and cancer. Despite this, exercise is not currently used in patients with liver failure or recovering from LT, due to a lack of robust evidence. Exercise may have the potential to improve the lives of people with liver disease and reduce the side-effects of LT surgery. The current standard of care for NHS patients awaiting LT is an advice leaflet. Evidence-based exercise programmes around the time of transplantation do not exist. Only a few small studies have indicated that supervised, hospital-based exercise can improve physical function and quality of life. AIMS: Investigators aim to determine the effect of a home-based exercise and motivation-support programme in patients undergoing LT on their quality of life after surgery. Investigators would also like to understand if exercise results in improvements in intricate measures of physical fitness and muscle function that account for changes in quality of life, and how the motivation-support component of the intervention enhances uptake and ongoing engagement of exercise pre and post LT.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

June 11, 2025

Last Update Submit

July 2, 2025

Conditions

Liver Transplant Surgery

Keywords

liver diseasequality of lifeLiver transplantExercise and motivation

Outcome Measures

Primary Outcomes (1)

  • The physical component score (PCS) from the short form-36 version 2.0 (SF-36v2) health-related Quality of Life questionnaire

    The primary outcome measure for this trial is the PCS from the SF-36v2 health-related QoL questionnaire at 24 weeks post LT. The SF-36v2 questionnaire includes 36 questions composed of eight multi-item scales, which reflect the impact of health problems on both the physical and mental condition of the patient.(A higher score reflects better quality of life. Two summary sub-scores can be calculated which are weighted combinations of the 8 scales, one to reflect the impact on physical function (PCS) and one to reflect the impact on psychological function, known as the mental component score (MCS).Scoring of the SF-36v2 questionnaire will based on the instructions provided in the SF-36v2 user's manual.

    Baseline (visit 1, week 0) up to 24 weeks post-LT

Secondary Outcomes (18)

  • Surgical complications -Comprehensive Complication Index (CCI):

    LT up to 24 weeks post-LT

  • Mental Component Score (MCS) of SF-36v2 health-related QoL questionnaire

    Baseline (visit 1, week 0) up to 24 weeks post-LT

  • Liver Frailty Index (LFI)

    Baseline (visit 1, week 0) up to 24 weeks post-LT

  • Duke activity status index (DASI):

    Baseline (visit 1, week 0) up to 24 weeks post-LT

  • Pre-LT mortality (*assessed up to day of LT)

    Baseline (visit 1, week 0) up to LT or the 48 week visit.

  • +13 more secondary outcomes

Study Arms (2)

Control: Group 2

ACTIVE COMPARATOR

Patient exercise advice leaflet before and after LT.

Other: Patient exercise advice leaflet before and after LT.

Group 1: Home-based exercise and motivation support programme

EXPERIMENTAL

Remotely-monitored home-based exercise and theory-based motivation support programme whilst on the LT waiting list (max. 12 months) through to 24 weeks post-LT.

Other: Home-based exercise and theory-based motivation support programme

Interventions

Home-based exercise and theory-based motivation support programmeOTHER

1. A remotely-monitored personalised home-based exercise programme (HBEP) and 2. An autonomous motivation enhancement programme, known as Empowering Physio, delivered to physiotherapists to support them in delivering the HBEP.

Group 1: Home-based exercise and motivation support programme
Patient exercise advice leaflet before and after LT.OTHER

Control

Control: Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (aged 18 years or over)
  • Patients listed for a cadaveric, primary LT at QEUHB or the RFH
  • Being an out-patient at the time of baseline trial visit (consent)

You may not qualify if:

  • Patients listed for LT for any of the following reasons:
  • super-urgent LT (according to the Kings College criteria)
  • multi-organ transplantation (e.g. combined liver and kidney transplant)
  • live-related donor LT
  • re-graft LT
  • Patients with an inability to safely comply with the exercise intervention due to:
  • severe hepatic encephalopathy (grade 3 or 4; or as judged by the clinical investigators)
  • oxygen-dependent hepato-pulmonary syndrome
  • Patients without liver failure, including:
  • liver cancer in the absence of cirrhosis
  • polycystic liver disease
  • rare metabolic/genetic conditions (e.g. glycogen storage disorders)
  • Refusal or lacks capacity to give informed consent to participate in the trial, at the point of study visit 1 (baseline)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Birmingham Clinical Trials Unit (BCTU)

Birmingham, B15 2TT, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Liver DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Digestive System DiseasesBehavior

Study Officials

  • Mathew Armstrong

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

July 14, 2025

Study Start

May 3, 2022

Primary Completion

November 1, 2025

Study Completion

May 1, 2026

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access
Informed Consent Form Access

Locations

GB(3)