Cirrhosis, Liver, Frailty, Liver Transplantation
Conditions
Keywords
Prehabilitation, Nutrition, Quality of life, Exercise, Cirrhosis
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.
Interventions
BEHAVIORALPrehabilitation
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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Canadian Donation and Transplantation Research Program
Canadian Association for the Study of the Liver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention | 12 months | Proportion of participants that adhere to the intervention protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the intervention | 24 weeks | Incidence of intervention-related adverse events |
| Impact of exercise program on frailty | At end of week-4, week-14, and week-24 | Interval change in liver frailty index, where a higher value indicates a higher degree of frailty |
| Impact of nutritional program on nutritional status | At end of week-4, week 14, and week-24 | 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 | At end of week-4, week 14, and week-24 | Interval change in the Chronic Liver Disease Questionnaire (CLDQ) score where lower values indicate worse health-related quality of life. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAmine Benmassaoud, MD
Research Institute of the McGill University Health Centre
Outcome results
None listed