NCT05237583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

January 24, 2022

Last Update Submit

April 14, 2026

Conditions

Liver TransplantationCirrhosis, LiverFrailty

Keywords

PrehabilitationNutritionQuality of lifeExerciseCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the intervention

    Proportion of participants that adhere to the intervention protocol

    12 months

Secondary Outcomes (4)

  • Safety of the intervention

    24 weeks

  • 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

  • Impact of psychological program on health-related quality of life

    At end of week-4, week 14, and week-24

Study Arms (1)

Prehabilitation

EXPERIMENTAL

Multimodal prehabilitation program

Behavioral: Prehabilitation

Interventions

PrehabilitationBEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (1)

  • Benmassaoud A, Gillis C, Geraci O, Martel M, Awasthi R, Barkun J, Chen T, Edgar L, Sebastiani G, Carli F, Bessissow A. Prehabilitation in patients with cirrhosis awaiting liver transplantation: protocol of a feasibility study. BMJ Open. 2024 Jun 25;14(6):e081362. doi: 10.1136/bmjopen-2023-081362.

    PMID: 38925705DERIVED

MeSH Terms

Conditions

Liver CirrhosisFrailtyMotor ActivityFibrosis

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Amine Benmassaoud, MD

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 14, 2022

Study Start

February 23, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)