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Home-based exercise and motivational programme before and after liver transplantation: ExaLT Trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13476586
Enrollment
266
Registered
2022-06-07
Start date
2022-05-03
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise before and after liver transplant Surgery

Interventions

Eligible participants will be randomised 1:1 to receive either: Group 1: Intervention group. Remotely-monitored home-based exercise and theory-based motivation support programme whilst on the LT wait

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult Patients (aged 18 years or over) 2. Patients listed for a cadaveric, primary liver transplantation (LT) at QEUHB or the RFH 3. Being an out-patient at the time of baseline trial visit (consent)

Exclusion criteria

Exclusion criteria: 1. Patient listed for Liver Transplant for any of the following reasons: 1.1. Super-urgent Liver Transplant (according to the Kings College criteria) 1.2. Multi-organ transplantation (e.g. combined liver and kidney transplant) 1.3. Live-related donor Liver Transplant 1.4. Re-graft Liver Transplant 2. Patients with an inability to safely comply with the exercise intervention due to the following conditions: 2.1. Severe hepatic encephalopathy (defined as grade 3 or 4; as judged by the principal or nominated co-investigators) 2.2. Oxygen-dependent hepato-pulmonary syndrome 3. Patients without liver failure, including: 3.1. Liver cancer in the absence of cirrhosis 3.2. Polycystic liver disease 3.3. Rare metabolic/genetic conditions (e.g. glycogen storage disorders) 4. Refusal or lacks capacity to give informed consent to participate in the trial, at the point of study visit 1

Design outcomes

Primary

MeasureTime frame
Physical component score (PCS) from the short form-36 version 2.0 (SF-36v2) health-related QoL questionnaire at 24 weeks post LT (scale 0-100).

Secondary

MeasureTime frame
Key secondary outcome measure: 1. Comprehensive Complication Index at 24 weeks post LT (scale 0-100). Other secondary outcome measures to be assessed at 24 weeks post LT (unless stated): 2. Mental Component Score (MCS) of SF-36v2 health-related QoL questionnaire 3. Liver Frailty Index (LFI), Duke Activity Score Index (DASI) 4. Pre-LT morbidity (UKELD, MELD-Na, hospital admissions) and mortality (*assessed up to day of LT) 5. Post-LT length of ICU/hospital stay and hospital re-admissions (frequency, duration [days]) 6. Post-LT 30, 90, 180 and 365 day mortality 7. Habitual physical activity levels (daily time spent in light, moderate and vigorous intensity physical activity) using Actigraph accelerometers 8. “Dose” of exercise completed (measure of the frequency, intensity and duration of exercise) 9. Adherence to Home-based exercise program (HBEP - intervention arm only) 10. Perceptions of the health care climate (how need supportive/empowering the physiotherapist is), measured using the Health Care Climate Questionnaire (HCCQ) 11. Basic psychological need satisfaction (i.e. feelings of autonomy, relatedness, competence), measured using the Basic Psychological Need Satisfaction in Exercise Scale (PNSE) 12. Self-determined motivation to exercise, using Behavioural Regulation in Exercise Questionaire-2 (BREQ-2)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026