Prehabilitation for Liver Transplant Candidates
(Prehab preLT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Disqualifiers: Hepatic decompensation, Heart disease, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
12678How 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.
12489Eligibility 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.
+8 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: PrehabilitationExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McGill University Health CentreMontréal, Canada
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Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
Canadian Donation and Transplantation Research ProgramCollaborator
Canadian Association for the Study of the LiverCollaborator
References
Physical Effects, Safety and Feasibility of Prehabilitation in Patients Awaiting Orthotopic Liver Transplantation, a Systematic Review. [2022]Prehabilitation improves surgical outcomes in patients undergoing surgery. However, patients preparing for orthotopic liver transplantation (OLT) are physically "frail" and suffer from comorbidities that generally hamper physical activity. This systematic review aims to evaluate the physical effects, safety and feasibility of prehabilitation in OLT candidates. Relevant articles were searched, in Embase, Web of Science, Cochrane, Medline and Google Scholar, to December 2021. Studies reporting on specified preoperative exercise programs, including adult OLT candidates with end-stage liver disease, with a model for end-stage liver disease (MELD) score ≥12 or Child-Pugh classification B/C, were included. This resulted in 563 potentially eligible studies, out of which eight were selected for inclusion, consisting of 1,094 patients (male sex 68%; mean age 51-61 years; mean MELD score 12-21). Six of the included studies were classified as low-quality by the GRADE system, and three studies had high risk for ineffectiveness of the training program according to the i-CONTENT tool. Significant improvement was observed in VO2 peak, 6-minute walking distance, hand grip strength, liver frailty index and quality of life. Feasibility ranged from an adherence of 38%-90% in unsupervised-to >94% in supervised programs. No serious adverse events were reported. In conclusion, prehabilitation in patients awaiting OLT appears to improve aerobic capacity, and seems feasible and safe. However, larger clinical trials are required to accurately examine the preoperative and postoperative effects of prehabilitation in this specific patient population.
An Outpatient Hospital-based Exercise Training Program for Patients With Cirrhotic Liver Disease Awaiting Transplantation: A Feasibility Trial. [2021]Time spent on the waiting list before liver transplantation (LT) provides an opportunity to optimize recipient fitness through prehabilitation, potentially reducing the physiological impact of major surgery. We assessed the feasibility and effectiveness of a 6-week exercise program in patients with cirrhotic liver disease awaiting LT.
Prehabilitation Program Improves Outcomes of Patients Undergoing Elective Liver Resection. [2020]Preoperative phase can be effectively used by multidisciplinary teams to optimize the surgical candidate to improve perioperative outcomes. The aim of our study was to evaluate the impact of prehabilitation program (PP) in patients undergoing elective liver resection (LR).
Quality of Life and Functional Mobility After Progressive Resistance Exercise in an Adolescent With a Liver Transplant. [2021]This case report describes physical therapy intervention using progressive resistance exercise (PRE) with the recipient of a liver transplant to improve physical fitness, quality of life, and functional mobility.
Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial. [2018]To validate the feasibility and tolerance of an intensive rehabilitation protocol initiated during the postoperative period in an intensive care unit (ICU) in liver transplant recipients.
Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. [2021]Frailty is associated with increased mortality both before and after liver transplantation (LT). There are no standardized exercise programs, in particular home-based exercise programs (HBEPs), for patients awaiting LT. The aim was to investigate the feasibility of such a program in patients awaiting LT. Patients were randomly selected from the Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises. Feasibility was based on patient eligibility (≥66% of waiting list), target recruitment (≥90% of n = 20), safety (no related serious adverse events), and adherence (≥66% adherence to 6-week HBEP). Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS]) were taken at baseline and at 6 and 12 weeks. 18 patients (50% male; median age, 55 years) were recruited. All domains of the study feasibility criteria were met. ISWT improved after 6 weeks (50 m; P ≤ 0.01) and 12 weeks (210 m; P ≤ 0.01), despite withdrawal of the telephone health calls. Similarly, improvements were seen in ADS (2700/day; P ≤ 0.01) and the SPPBT (2.5; P = 0.02) after 12 weeks. There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04). In conclusion, a 12-week HBEP, incorporating both easy-to-apply resistance and aerobic exercises, is safe and feasible in patients awaiting LT. Measures of aerobic and functional capacity demonstrate trends toward improvement that warrant further investigation in a randomized controlled trial.
Patient and Caregiver Attitudes and Practices of Exercise in Candidates Listed for Liver Transplantation. [2019]Impaired physical capacity increases peri-liver transplant complications. Patient perceptions regarding exercise prior to transplantation are not known.
The role of prehabilitation on short-term outcomes after liver transplantation: A review of the literature and expert panel recommendations. [2023]Prehabilitation programs as part of ERAS protocols are being increasingly used in multiple surgeries, improving postoperative outcomes. Data regarding prehabilitation programs in patients awaiting liver transplantation and their outcomes is scarce.
Randomized clinical trial of prehabilitation in colorectal surgery. [2022]'Prehabilitation' is an intervention to enhance functional capacity in anticipation of a forthcoming physiological stressor. In patients scheduled for colorectal surgery, the extent to which a structured prehabilitation regimen of stationary cycling and strengthening optimized recovery of functional walking capacity after surgery was compared with a simpler regimen of walking and breathing exercises.