Prehabilitation for Patients Awaiting Liver Transplantation (Prehab preLT)

April 14, 2026 updated by: Amine Benmassaoud, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation
Multimodal prehabilitation program
Behavioral: Prehabilitation
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the intervention
Time Frame: 24 weeks
Incidence of intervention-related adverse events
24 weeks
Impact of exercise program on frailty
Time Frame: 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
At end of week-4, week-14, and week-24
Impact of nutritional program on nutritional status
Time Frame: 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
At end of week-4, week 14, and week-24
Impact of psychological program on health-related quality of life
Time Frame: 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.
At end of week-4, week 14, and week-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Canadian Donation and Transplantation Research Program
Canadian Association for the Study of the Liver

Investigators

  • Principal Investigator: Amine Benmassaoud, MD, Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2022

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-7646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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