Cirrhosis, LiverPrehab preLTNCT05237583
Prehabilitation for Patients Awaiting Liver Transplantation
A study testing Prehabilitation in people with Cirrhosis, Liver and Liver Transplantation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Liver Transplantation, Frailty
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Altered hemodynamics
- Significant heart disease
- Awaiting combined organ transplantation
- Awaiting repeat liver transplantation
- Condition limiting mobilization and/or exercise, or recurrent falls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial
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.
Read the 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.
- Conditions
- Cirrhosis, Liver, Liver Transplantation, Frailty
- Being tested
- Prehabilitation
- Keywords
- Prehabilitation, Nutrition, Quality of life, Exercise, Cirrhosis
- Medical subject headings
- Liver Cirrhosis, Frailty, Motor Activity, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Multimodal prehabilitation program Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
Proportion of participants that adhere to the intervention protocol
Measured: 12 months
Secondary outcomes (4)
Safety of the intervention
Incidence of intervention-related adverse events
Measured: 24 weeks
Impact of exercise program on frailty
Interval change in liver frailty index, where a higher value indicates a higher degree of frailty
Measured: At end of week-4, week-14, and week-24
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
Measured: At end of week-4, week 14, and week-24
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.
Measured: At end of week-4, week 14, and week-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start23 Feb 2022
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Donation and Transplantation Research Program, Canadian Association for the Study of the Liver
- Responsible party
- Principal investigator, Amine Benmassaoud, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Amine Benmassaoud, MD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237583
- Sponsor's protocol ID
- 2021-7646
- Acronym
- Prehab preLT
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38925705
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial
- ClinicalTrials.gov ID
- NCT05237583
- Acronym / sponsor ID
- Prehab preLT / 2021-7646
- Conditions
- Cirrhosis, Liver, Liver Transplantation, Frailty
- Keywords
- Prehabilitation, Nutrition, Quality of life, Exercise, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Donation and Transplantation Research Program, Canadian Association for the Study of the Liver
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: PrehabilitationMultimodal prehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationAll 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. | Behavioural | Prehabilitation |
Primary outcome
Feasibility of the intervention
Time frame: 12 months
Proportion of participants that adhere to the intervention protocol
4 secondary outcomes
Safety of the intervention
Time frame: 24 weeks
Impact of exercise program on frailty
Time frame: At end of week-4, week-14, and week-24
Impact of nutritional program on nutritional status
Time frame: At end of week-4, week 14, and week-24
Impact of psychological program on health-related quality of life
Time frame: At end of week-4, week 14, and week-24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 38925705Benmassaoud 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.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amine Benmassaoud, MD principal investigator
Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Cirrhosis, Liver and Liver Transplantation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.