ExaLT Trial
Research type
Research Study
Full title
A PHASE IIb, RANDOMISED-CONTROLLED, TWO-CENTRE CLINICAL TRIAL (EXALT) ON THE EFFICACY OF A HOME-BASED EXERCISE AND MOTIVATIONAL PROGRAMME IN PATIENTS BEFORE AND AFTER LIVER TRANSPLANTATION
IRAS ID
295426
Contact name
Matthew Armstrong
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN13476586
Clinicaltrials.gov Identifier
NIHR EME, 129318
Duration of Study in the UK
3 years, 11 months, 28 days
Research summary
Exercise is one of the most powerful medical therapies available and has proven benefits to patients with diseases like diabetes, heart disease and cancer. Currently due to lack of research evidence, evidence-based exercise programmes are not currently used in patients with liver failure or patients who are recovering after liver transplant. The current standard of care is an exercise advice leaflet. The aim of this randomised clinical trial is to determine the effect of a home-based exercise and motivation-support programme in patients undergoing liver transplantation on their quality of life after surgery. Furthermore, we hope to better understand how the exercise works and what motivational support is needed to enable patients to engage with exercise in the long-term, not only while waiting for a liver transplant, but also long after the transplant is completed.
This is a two centre randomised trial for patients with end-stage liver disease who are on the liver transplant waiting list. 266 eligible participants will be randomised 1:1 to receive either home-based exercise and motivation support programme (intervention arm) OR the standardised patient exercise advice leaflet (control arm). The home based therapy will be delivered and supervised by specialist physiotherapists before and 24-weeks after liver transplantation. Measurements in the form of blood tests, nutritional/physical assessments and health questionnaires will be used to collect data to compare the two groups after liver transplant. The main outcome measure is a functional quality of life questionnaire (SF-36v2) 24 weeks after liver transplantation.
In addition, there is an optional sub-study (n=100) to the ExaLT trial, which involves a more detailed assessment of muscle size (using ultrasound), exercise capacity/fitness (using cardiopulmonary exercise testing, shuttle walk test) and blood tests, to investigate the effect of exercise and how exercise works in patient before and after liver transplantation.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0067
Date of REC Opinion
1 Apr 2022
REC opinion
Further Information Favourable Opinion