Prehabilitation for Patients Awaiting Liver Transplantation

NCT ID: NCT05237583

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Cirrhosis, Liver Liver Transplantation Frailty

Keywords

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Prehabilitation Nutrition Quality of life Exercise Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prehabilitation

Multimodal prehabilitation program

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Donation and Transplantation Research Program

UNKNOWN

Sponsor Role collaborator

Canadian Association for the Study of the Liver

UNKNOWN

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Amine Benmassaoud

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amine Benmassaoud, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute of the McGill University Health Centre

Locations

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McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Amine Benmassaoud, MD

Role: CONTACT

Phone: 5149341934

Email: [email protected]

Olivia Geraci

Role: CONTACT

Phone: 5149341934

Email: [email protected]

Facility Contacts

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Amine Benmassaoud, MD

Role: primary

Olivia Geraci

Role: backup

References

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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.

Reference Type DERIVED
PMID: 38925705 (View on PubMed)

Other Identifiers

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2021-7646

Identifier Type: -

Identifier Source: org_study_id