Clinical trial NCT06808945: Preoperative Prehabilitation in Patients Planned for Liver Transplantation
Official title: Preoperative PREhabilitation in Patients Planned for LIVER Transplantation (PRELIVERT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant; Complications
Physical Inactivity
Keywords: prehabilitation
liver transplant
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Rijndam Revalidatiecentrum
name: Capri Hartrevalidatie
First posted: 2025-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the feasibility and effectiveness of a home-based multimodal prehabilitation program in patients anticipated to be waitlisted for LT. Patients will participate in an eight week prehabilitation program consisting of physical exercise, nutritional support, smoking cessation and psychological counselling.

Detailed description: Rationale: Patients who qualify for liver transplantation (LT) are mostly frail due to their underlying liver disease. Frailty is comprised by a decreased functional capacity, impaired aerobic capacity, and sarcopenia. It is well known that frailty leads to both increased pre- and post-transplantation morbidity as well as mortality. For various surgical populations prehabilitation was demonstrated to be feasible, effective, and to improve surgical outcomes. Few studies on this subject have been conducted in the patient population awaiting liver transplantation.

Objective: The primary objective is to determine the feasibility of a semi-supervised homebased prehabilitation program for patients to be waitlisted for LT. The secondary objectives are to assess the effectiveness of this program and possible improvements of surgical outcomes (e.g. less complications, faster recovery, and shorter length of hospital stay).

Study design: This is a multi-centre, single arm, prospective cohort (pilot) study. It will take place at the Erasmus Medical Center in Rotterdam, the Netherlands.

Study population: Adult patients who are anticipated to be waitlisted for LT, who have no contra-indications to physical exercise training.

Intervention: Patients will participate in an eight-week semi-supervised home based prehabilitation program. This program consists of physical exercise, nutritional support provided by a dietician, smoking cessation, and psychological counselling. The program will be personalized and consists of two training sessions per week. Through the Oefenportaal platform the physical therapist will supervise the exercises and monitor patients' adherence to the program.

Main study parameters/endpoints: The main study parameter/endpoint is the feasibility of the prehabilitation program (program satisfaction, compliance, and percentage of patients willing to participate in the prehabilitation program). A secondary outcome is the effectiveness of the program. Furthermore, postoperative outcomes after 30 days will be collected.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will participate in an eight-week prehabilitation program prior to anticipated LT. The prehabilitation sessions take approximately 3-5 hours per week. To lower the burden for patients, the majority of the program takes place at home using digital tools. During the first week patients are seen at the Erasmus MC for an intake (about 60 minutes). All study appointments will be combined with regular appointments for screening if possible. Furthermore, patients are expected on-site at the start and after completion of the prehabilitation program to undergo measurements (90 minutes). Also, they have to complete questionnaires at home three times total (two times 20 minutes, one time 10 minutes).

Since the prehabilitation program is based on existing care, we expect minimal risks for the patients. Participants are anticipated to benefit from the pilot prehabilitation program considering a better physical fitness and a behavioural change towards a healthier lifestyle.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years,
* Anticipated waitlisting for LT,
* Speaks the Dutch language,
* Understands the purpose of the study and has given written informed consent.

Exclusion Criteria:

* Experienced a major adverse cardiovascular event in the past six months,
* Experienced a cerebrovascular incident in the past six months,
* Medical history of an uncontrolled heart rhythm disorder,
* Hepatic encephalopathy grade 3 or 4,
* Acute liver failure,
* Acute-on-chronic liver failure,
* Hospitalization at start of the study.
* Non-treated esophageal varices (i.e., no previous variceal eradication endoscopy or adequately dosed NSBB)

Primary outcomes:
measure: Program satisfaction
timeFrame: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
measure: Program compliance
timeFrame: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
measure: Percentage of patients willing to participate in the prehabilitation program
timeFrame: At the outpatient clinic, when patients make their appointment for screening for LT
Secondary outcomes:
measure: Aerobic capacity
timeFrame: At start of the program, when patients are admitted for screening, they will perform a CPET as baseline. After eight weeks of home-based training the CPET will be reassessed.
measure: Sarcopenia
timeFrame: At baseline (before start prehabilitation program) and after eight weeks.
measure: Anthropometry
timeFrame: At baseline (before start prehabilitation program) and after eight weeks.
measure: Functional capacity
timeFrame: At baseline (before start prehabilitation program) and after eight weeks.
measure: Functional mobility
timeFrame: At baseline (before start prehabilitation program) and after eight weeks.
measure: Physical activity level
timeFrame: At baseline (before start prehabilitation program) and after eight weeks patients will wear the ActiGraph accelerometer for 7 days.
measure: Hand grip strength
timeFrame: At baseline (before start prehabilitation program) and after eight weeks.
measure: Quadriceps strength
timeFrame: At baseline (before start prehabilitation program) and after eight weeks
measure: Quality of life assessment
timeFrame: At baseline (before start prehabilitation program) and after eight weeks
measure: Perceived fatigue assessment
timeFrame: At baseline (before start prehabilitation program) and after eight weeks
measure: Postoperative outcomes up to 30 days post LT assessment
timeFrame: Through study completion (30 days after LT)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References: