Clinical trial NCT05237583: Prehabilitation for Patients Awaiting Liver Transplantation
Official title: Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis, Liver
Liver Transplantation
Frailty
Keywords: Prehabilitation
Nutrition
Quality of life
Exercise
Cirrhosis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Donation and Transplantation Research Program
name: Canadian Association for the Study of the Liver
First posted: 2022-02-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Safety of the intervention
timeFrame: 24 weeks
measure: Impact of exercise program on frailty
timeFrame: At end of week-4, week-14, and week-24
measure: Impact of nutritional program on nutritional status
timeFrame: At end of week-4, week 14, and week-24
measure: Impact of psychological program on health-related quality of life
timeFrame: At end of week-4, week 14, and week-24
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Amine Benmassaoud, MD
role: PRINCIPAL_INVESTIGATOR
References: