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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05237583
Other study ID # 2021-7646
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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