Prehabilitation for Patients Awaiting Liver Transplantation

Not Applicable

Recruiting

• Conditions: Liver Transplantation; Frailty; Cirrhosis, Liver
• Interventions: Behavioral: Prehabilitation

• Registration Number: NCT05237583
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

This study will assess the feasibility, safety and effectiveness of a structured prehabilitation program combining exercise training, nutritional optimization and psychological support for patients with cirrhosis awaiting liver transplantation.

Detailed Description

Due to their chronic liver disease, patients with cirrhosis awaiting liver transplantation develop low muscle mass, poor nutritional status and decreased reserves putting them at high risk of postoperative complications, prolonged hospital stay, and failed discharge home after liver transplantation. Prehabilitation aims to optimize a patient before they undergo a major surgery. These programs combine exercise training, with nutritional optimization and psychological support. Together, these contribute to improve their muscle mass, tolerance to exercise, and nutritional status. The current study will assess whether an individualized and structured prehabilitation program combining supervised exercise training, nutritional optimization and psychological support will benefit patients with cirrhosis awaiting liver transplantation.

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-14
• Study Start: 2022-02-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-01
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age above 18 years
• Diagnosis of cirrhosis, based on a combination of clinical, laboratory, imaging, or histology
• Active on the liver transplant waiting list of the MUHC

Exclusion Criteria

• Biological Model for End Stage Liver Disease >20
• Hepatic decompensation within the last month
• High risk varices not on primary or secondary prevention
• Recurrent large volume paracentesis
• Persistent hepatic encephalopathy
• Platelets <20,000/µL, or hemoglobin <80g/L
• Altered hemodynamics
• Significant heart disease
• Awaiting combined organ transplantation
• Awaiting repeat liver transplantation
• Condition limiting mobilization and/or exercise, or recurrent falls

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation	Multimodal prehabilitation program

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	12 months	Proportion of participants that adhere to the intervention protocol

Secondary Outcome Measures

Name	Time	Method
Safety of the intervention	24 weeks	Incidence of intervention-related adverse events
Impact of psychological program on health-related quality of life	At end of week-4, week 14, and week-24	Interval change in the Chronic Liver Disease Questionnaire (CLDQ) score where lower values indicate worse health-related quality of life.
Impact of exercise program on frailty	At end of week-4, week-14, and week-24	Interval change in liver frailty index, where a higher value indicates a higher degree of frailty
Impact of nutritional program on nutritional status	At end of week-4, week 14, and week-24	Interval change in Royal Free Hospital Global Assessment status, where participants are classified as well nourished, moderately malnourished, or severely malnourished

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada