Prehabilitation for Patients Awaiting Liver Transplantation

Frailty Clinical Trial

— Prehab preLT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237583
• Other study ID #: 2021-7646
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Amine Benmassaoud, MD
• Phone: 5149341934
• Email: amine.benmassaoud[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Frailty
• Liver Cirrhosis
• Liver Transplantation

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Association for the Study of the Liver, Canadian Donation and Transplantation Research Program

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention	Proportion of participants that adhere to the intervention protocol	12 months
Secondary	Safety of the intervention	Incidence of intervention-related adverse events	24 weeks
Secondary	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
Secondary	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
Secondary	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