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Prehabilitation for Patients Awaiting Liver Transplantation (Prehab preLT)

Primary Purpose

Cirrhosis, Liver, Liver Transplantation, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Prehabilitation, Nutrition, Quality of life, Exercise, Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University Health CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabilitation

Arm Description

Multimodal prehabilitation program

Outcomes

Primary Outcome Measures

Feasibility of the intervention
Proportion of participants that adhere to the intervention protocol

Secondary Outcome Measures

Safety of the intervention
Incidence of intervention-related adverse events
Impact of exercise program on frailty
Interval change in liver frailty index, where a higher value indicates a higher degree of frailty
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
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.

Full Information

First Posted
January 24, 2022
Last Updated
October 8, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05237583
Brief Title
Prehabilitation for Patients Awaiting Liver Transplantation
Acronym
Prehab preLT
Official Title
Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Liver Transplantation, Frailty
Keywords
Prehabilitation, Nutrition, Quality of life, Exercise, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
Multimodal prehabilitation program
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of the intervention
Description
Proportion of participants that adhere to the intervention protocol
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety of the intervention
Description
Incidence of intervention-related adverse events
Time Frame
24 weeks
Title
Impact of exercise program on frailty
Description
Interval change in liver frailty index, where a higher value indicates a higher degree of frailty
Time Frame
At end of week-4, week-14, and week-24
Title
Impact of nutritional program on nutritional status
Description
Interval change in Royal Free Hospital Global Assessment status, where participants are classified as well nourished, moderately malnourished, or severely malnourished
Time Frame
At end of week-4, week 14, and week-24
Title
Impact of psychological program on health-related quality of life
Description
Interval change in the Chronic Liver Disease Questionnaire (CLDQ) score where lower values indicate worse health-related quality of life.
Time Frame
At end of week-4, week 14, and week-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amine Benmassaoud, MD
Phone
5149341934
Email
amine.benmassaoud@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Geraci
Phone
5149341934
Email
olivia.geraci@muhc.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amine Benmassaoud, MD
Organizational Affiliation
Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amine Benmassaoud, MD
Phone
5149341934
Email
amine.benmassaoud@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Olivia Geraci
Phone
5149341934
Email
olivia.geraci@muhc.mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Prehabilitation for Patients Awaiting Liver Transplantation

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