Prehabilitation for Liver Transplant Candidates

(Prehab preLT Trial)

Recruiting at 1 trial location

Overseen By Olivia Geraci

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Hepatic decompensation, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Prehabilitation to help individuals with cirrhosis (serious liver damage) prepare for a liver transplant. The program includes exercise, improved nutrition, and mental health support. The goal is to determine if this program is safe and beneficial for those awaiting a new liver. It suits individuals with cirrhosis who are already on the liver transplant waiting list and do not have severe complications. As an unphased trial, it offers a unique opportunity to improve health and readiness for a liver transplant.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for liver transplant candidates?

Research has shown that prehabilitation programs are safe and beneficial for individuals awaiting organ transplants. These programs include exercise, improved nutrition, and mental health support. Studies specifically highlight the safety of prehabilitation for those awaiting a liver transplant. These programs help patients become fitter and better prepared for surgery, with no major safety issues reported. Overall, patients tolerate prehabilitation well, and it can lead to better outcomes for those preparing for liver transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prehabilitation for liver transplant candidates because it represents a proactive approach unlike traditional post-surgery rehabilitation. While standard care typically focuses on recovery after the transplant, prehabilitation aims to optimize patients' physical and mental health before surgery. This multimodal program can include exercise, nutrition, and psychological support, potentially making patients stronger and better prepared for the challenges of surgery. By enhancing patients' overall resilience beforehand, prehabilitation may improve surgical outcomes and reduce recovery times, making it a promising advancement in transplant care.

What evidence suggests that this prehabilitation program is effective for liver transplant candidates?

Research has shown that prehabilitation, which includes exercise, nutrition, and psychological support, can improve fitness in individuals awaiting organ transplants, such as liver transplants. Previous studies found it safe and feasible for patients on the liver transplant waiting list. In this trial, participants will undergo a multimodal prehabilitation program designed to strengthen and improve health before surgery, potentially aiding in better recovery afterward. Although more research is needed, early results suggest these programs can benefit liver transplant candidates. ^{1 2 4 5 6}

Who Is on the Research Team?

Amine Benmassaoud, MD

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are on the liver transplant waiting list with diagnosed cirrhosis. They must not have severe end-stage liver disease, recent hepatic decompensation, low blood counts, significant heart issues, or conditions that limit movement or cause frequent falls.

Inclusion Criteria

I am over 18 years old.

Active on the liver transplant waiting list of the MUHC

I have been diagnosed with cirrhosis.

Exclusion Criteria

Biological Model for End Stage Liver Disease >20

My liver has not failed in the last month.

I have had multiple large fluid removals from my abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a multimodal prehabilitation program combining exercise training, nutritional optimization, and psychological support

24 weeks

Regular visits for supervised exercise and assessments

Follow-up

Participants are monitored for safety and effectiveness after the prehabilitation program

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation

Trial Overview

The study tests a prehabilitation program for those awaiting liver transplants. It includes exercise training, nutritional support and psychological care to see if it's doable, safe and effective in improving patient outcomes before surgery.

How Is the Trial Designed?

Group I: Prehabilitation Experimental Treatment 1 Intervention

Multimodal prehabilitation program

Prehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in United States as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Canadian Donation and Transplantation Research Program

Collaborator

Trials

2

Recruited

40+

Canadian Association for the Study of the Liver

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Prehabilitation programs involving exercise training before liver transplantation may improve short-term functional outcomes, with studies showing positive effects on aerobic capacity and muscle strength, although evidence is limited and underpowered.

The only observational study assessing postoperative outcomes suggested a non-significant trend towards reduced readmission rates and shorter hospital stays for patients who underwent prehabilitation, indicating potential benefits without significant harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of prehabilitation on short-term outcomes after liver transplantation: A review of the literature and expert panel recommendations. Vinaixa, C., Martínez Palli, G., Milliken, D., et al.[2023]

A 12-week home-based exercise program (HBEP) for patients awaiting liver transplantation was found to be safe and feasible, meeting all study criteria for patient eligibility, recruitment, and adherence.

Participants showed significant improvements in aerobic capacity (measured by the incremental shuttle walk test) and functional capacity after 6 and 12 weeks, suggesting that such exercise programs could benefit patients on the liver transplant waiting list.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. Williams, FR., Vallance, A., Faulkner, T., et al.[2021]

Prehabilitation programs for patients awaiting orthotopic liver transplantation (OLT) significantly improve physical fitness measures such as VO2 peak, walking distance, and hand grip strength, indicating enhanced aerobic capacity and quality of life.

The review included 1,094 patients and found that prehabilitation is generally safe, with no serious adverse events reported, although adherence rates varied and larger trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Effects, Safety and Feasibility of Prehabilitation in Patients Awaiting Orthotopic Liver Transplantation, a Systematic Review. Jetten, WD., Hogenbirk, RNM., Van Meeteren, NLU., et al.[2022]

A 6-week supervised exercise program for patients with cirrhotic liver disease awaiting liver transplantation was feasible, with 56% of participants completing it, indicating that such prehabilitation can be implemented effectively.

Participants in the exercise group showed a significant improvement in peak oxygen consumption (VO2peak), increasing from 16.2 to 18.5 mL/kg/min, while the control group experienced a decline, suggesting that exercise can enhance cardiopulmonary fitness before major surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Outpatient Hospital-based Exercise Training Program for Patients With Cirrhotic Liver Disease Awaiting Transplantation: A Feasibility Trial. Morkane, CM., Kearney, O., Bruce, DA., et al.[2021]

A survey of 368 liver transplant patients and their caregivers revealed that most participants view exercise as important for their health, with patients typically exercising three times a week for about 30 minutes, primarily through walking.

Despite a strong willingness to exercise, 70% of patients reported fatigue as a major barrier, indicating a need for tailored exercise recommendations and support from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Caregiver Attitudes and Practices of Exercise in Candidates Listed for Liver Transplantation. Chascsa, DM., Lai, JC., Dunn, MA., et al.[2019]

Progressive resistance exercise (PRE) was effective in improving strength, endurance, and overall quality of life in an adolescent following a liver transplant, as demonstrated over a 20-week outpatient physical therapy program.

The intervention led to measurable improvements in functional mobility and fitness levels, suggesting that PRE-based training can be a beneficial rehabilitation strategy for adolescents post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life and Functional Mobility After Progressive Resistance Exercise in an Adolescent With a Liver Transplant. Burkhardt, JA., Rapport, MJK.[2021]

In a study of 112 patients scheduled for colorectal surgery, a simpler regimen of walking and breathing exercises led to a greater improvement in functional walking capacity compared to a structured regimen of stationary cycling and strengthening exercises.

At the end of the prehabilitation period, 47% of patients in the walking group showed improvement in walking capacity, compared to only 22% in the cycling group, highlighting the unexpected effectiveness of the simpler approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of prehabilitation in colorectal surgery. Carli, F., Charlebois, P., Stein, B., et al.[2022]

A prehabilitation program (PP) for patients undergoing elective liver resection significantly reduced overall postoperative morbidity from 52.9% to 30%, indicating improved safety and recovery outcomes.

Patients in the PP group also experienced enhanced quality of life and a trend towards cost savings, with a 16.5% reduction in median costs, suggesting that preoperative optimization can be both effective and economically beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation Program Improves Outcomes of Patients Undergoing Elective Liver Resection. Wang, B., Shelat, VG., Chow, JJL., et al.[2020]

An intensive rehabilitation protocol initiated in the ICU for liver transplant recipients was well tolerated, with a low incidence of adverse events (1.06% in the experimental group).

Patients in the experimental group experienced quicker recovery milestones, such as sitting up sooner (2.6 days vs. 9.7 days) and resuming intestinal transit earlier (3.7 days vs. 5.6 days), suggesting that early rehabilitation can enhance recovery post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial. Maffei, P., Wiramus, S., Bensoussan, L., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10039771/

Prehabilitation in Adult Solid Organ Transplant Candidates

In conclusion, prehabilitation is an effective method for improving aerobic fitness in kidney-, lung-, liver-, and heart transplant candidates ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0955470X24000181

Prehabilitation in patients awaiting liver transplantation

Overall, it appears that prehabilitation with exercise training is feasible, and safe in patients awaiting LT. Higher quality and larger studies are needed to ...

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nature.com

nature.com/articles/s44355-024-00003-x

Optimizing the liver transplant candidate | npj Gut and Liver

The purpose of this review is to highlight common and best practices in liver transplant evaluation and management, particularly on how to best optimize a ...

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frontierspartnerships.org

frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2022.10330/full

Physical Effects, Safety and Feasibility of Prehabilitation in ...

Previous studies showed that prehabilitation programs are feasible, safe, and effective in patients scheduled for major abdominal surgery (7-9).

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03584646

Prehabilitation Intervention to Maximize Early Recovery ...

This is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the PRIMER intervention in improving physical ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9492850/

Physical Effects, Safety and Feasibility of Prehabilitation in ...

Prehabilitation improves surgical outcomes in patients undergoing surgery. However, patients preparing for orthotopic liver transplantation (OLT) ...