Home-based EXercise and motivAtional Program Before and After Liver Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Investigators intend to perform a clinical trial, in which patients will be randomly allocated to receive either the home-based exercise/motivation support programme (intervention group) or a patient advice leaflet (control group) whilst on the LT waiting list. The intervention will begin whilst patients are on the LT waiting list and end 6 months after LT. The intervention will consist of regular strength and endurance exercises, tailored to each patient's level of fitness. During clinic visits and via telephone calls a physiotherapist will provide motivational support throughout the exercise programme. The trial will involve recruiting 266 patients over two years from two LT hospitals in England. Investigators shall assess the effectiveness of the intervention by measuring quality of life before and after the study period in both groups of patients. The intervention will be deemed effective if quality of life scores are higher with the intervention than the control group.

Conditions

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Liver Transplant Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control: Group 2

Patient exercise advice leaflet before and after LT.

Group Type ACTIVE_COMPARATOR

Patient exercise advice leaflet before and after LT.

Intervention Type OTHER

Control

Group 1: Home-based exercise and motivation support programme

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.

Group Type EXPERIMENTAL

Home-based exercise and theory-based motivation support programme

Intervention Type OTHER

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.

Interventions

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Home-based exercise and theory-based motivation support programme

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.

Intervention Type OTHER

Patient exercise advice leaflet before and after LT.

Control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No