Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial
Overview
- Phase
- N/A
- Intervention
- Prehabilitation
- Conditions
- Cirrhosis, Liver
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Feasibility of the intervention
- Status
- Completed
- Last Updated
- 16 days ago
Overview
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.
Investigators
Amine Benmassaoud
Study Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Arms & Interventions
Prehabilitation
Multimodal prehabilitation program
Intervention: Prehabilitation
Outcomes
Primary Outcomes
Feasibility of the intervention
Time Frame: 12 months
Proportion of participants that adhere to the intervention protocol
Secondary Outcomes
- Safety of the intervention(24 weeks)
- Impact of psychological program on health-related quality of life(At end of week-4, week 14, and week-24)
- Impact of exercise program on frailty(At end of week-4, week-14, and week-24)
- Impact of nutritional program on nutritional status(At end of week-4, week 14, and week-24)