Preoperative Prehabilitation in Patients Planned for Liver Transplantation (PRELIVERT)

Erasmus University

Status: Enrolling

Conditions: Physical Inactivity; Liver Transplant; Complications

Treatments: Other: Prehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT06808945

NL85306.078.23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Home based prehabilitation

Experimental group

Description:

Participants will be subjected to a training period of eight weeks of a home-based multimodal prehabilitation program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling.

Treatment:

Other: Prehabilitation program