Prehabilitation for Patients Awaiting Liver Transplantation

Study Overview
=================
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.

Official Title
-----------------
Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial

Conditions
-----------------
Frailty, Cirrhosis, Liver, Liver Transplantation

Intervention / Treatment
-----------------
* Behavioral: Prehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>Multimodal prehabilitation program | Behavioral: Prehabilitation<br>* All participants will be offered a multimodal prehabilitation program. This program will include an individualized and supervised aerobic and resistance exercise training program, nutritional optimization, and psychological support. The program will last 6 months or until liver transplantation, whichever comes first.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention | Proportion of participants that adhere to the intervention protocol | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, Prehabilitation, Nutrition, Quality of life, Exercise