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Completed

NCT Number: NCT05237583

Prehabilitation for Patients Awaiting Liver Transplantation

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.

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Key information

Conditions

Cirrhosis, Liver Behavior Digestive System Diseases Fibrosis Frailty Liver Cirrhosis Liver Diseases Liver Transplantation Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Behavioral

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.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 12 months

    Proportion of participants that adhere to the intervention protocol

Secondary outcomes

  1. Safety of the intervention

    Time frame: 24 weeks

    Incidence of intervention-related adverse events

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Prehab preLT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2022
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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