Prehabilitation for Liver Transplant Candidates

(Prehab preLT Trial)

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

Trial Summary

What is the purpose of this trial?

This trial will test if a program combining exercise, nutrition, and mental health support can help patients with cirrhosis become stronger and healthier before their surgery.

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 data supports the effectiveness of the treatment Prehabilitation for Liver Transplant Candidates?

Research shows that prehabilitation, which includes exercise programs before surgery, can improve physical fitness, walking distance, and quality of life for patients waiting for a liver transplant. It is considered safe and feasible, with no serious side effects reported. ^{1 2 3 4 5}

Is prehabilitation safe for liver transplant candidates?

Prehabilitation, which includes exercise programs for liver transplant candidates, appears to be safe with no serious adverse events reported in studies. It is feasible and shows potential benefits in improving physical capacity, but larger studies are needed to confirm these findings. ^{1 2 6 7 8}

How is prehabilitation unique for liver transplant candidates?

Prehabilitation for liver transplant candidates is unique because it focuses on improving physical fitness and overall health before surgery through a structured exercise program, which can enhance recovery and reduce surgical risks. Unlike other treatments that may focus solely on medical management, prehabilitation involves a multidisciplinary approach to optimize the patient's condition before the transplant. ^{1 2 4 8 9}

Research Team

Amine Benmassaoud, MD

Principal Investigator

Research Institute of the McGill University Health Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Effects, Safety and Feasibility of Prehabilitation in Patients Awaiting Orthotopic Liver Transplantation, a Systematic Review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An Outpatient Hospital-based Exercise Training Program for Patients With Cirrhotic Liver Disease Awaiting Transplantation: A Feasibility Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Prehabilitation Program Improves Outcomes of Patients Undergoing Elective Liver Resection. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Patient and Caregiver Attitudes and Practices of Exercise in Candidates Listed for Liver Transplantation. [2019]

8. Denmark 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of prehabilitation in colorectal surgery. [2022]