Preoperative Prehabilitation in Patients Planned for Liver Transplantation

NCT ID: NCT06808945

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2026-07-31

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.

Conditions

Liver Transplant; Complications; Physical Inactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home based prehabilitation

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.

Group Type: EXPERIMENTAL

Prehabilitation program

Intervention Type: OTHER

Participants will be subjected to an eight week home-based multimodal prehabilitaiton program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling.

Interventions

Prehabilitation program

Participants will be subjected to an eight week home-based multimodal prehabilitaiton program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijndam Revalidatiecentrum

UNKNOWN

Sponsor Role: collaborator

Capri Hartrevalidatie

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Roeland F. de Wilde

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Lysanne P.M. Beuk

Role: CONTACT

l.p.m.beuk@erasmusmc.nl

+31615822753

Facility Contacts

Lysanne P.M. Beuk

Role: primary

l.p.m.beuk@erasmusmc.nl

+31615822753

Other Identifiers

NL85306.078.23

Identifier Type: -

Identifier Source: org_study_id