Preoperative Prehabilitation in Patients Planned for Liver Transplantation

NCT06808945 | Recruiting

• 1 other identifier: NL85306.078.23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications; Physical Inactivity

Keywords

prehabilitation; liver transplant

Outcome Measures

Primary Outcomes (3)

• Program satisfaction

  Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)

  At completion of the prehabilitation program (8 weeks after baseline/screening for LT)

• Program compliance

  Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.

  At completion of the prehabilitation program (8 weeks after baseline/screening for LT)

• Percentage of patients willing to participate in the prehabilitation program

  It will be registered which patients are willing and not willing to participate

  At the outpatient clinic, when patients make their appointment for screening for LT

Secondary Outcomes (11)

• Aerobic capacity

  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.

• Sarcopenia

  At baseline (before start prehabilitation program) and after eight weeks.

• Anthropometry

  At baseline (before start prehabilitation program) and after eight weeks.

• Functional capacity

  At baseline (before start prehabilitation program) and after eight weeks.

• Functional mobility

  At baseline (before start prehabilitation program) and after eight weeks.

Study Arms (1)

Home based prehabilitation

EXPERIMENTAL

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.

Other: Prehabilitation program

Interventions

Prehabilitation program 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.

Home based prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Rijndam Revalidatiecentrum: collaborator
• Capri Hartrevalidatie: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015 CN, Netherlands

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Lysanne P.M. Beuk

CONTACT

+31615822753; l.p.m.beuk@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: February 5, 2025
• Study Start: October 2, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)