Prehabilitation and Posttransplant Training Program in Liver Transplantation (PreLiveR-T)

Maria dels Angels Cebria i Iranzo, PT, PhD

Status: Invitation-only

Conditions: Liver Transplant; Complications; Hepatic Carcinoma; Cirrhosis, Liver

Treatments: Other: Prehabilitation and posttransplant training program; Other: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04246970

2019/0227

Details and patient eligibility

About

PreLiveR-T consists of a prospective randomized clinical trial conducted in an adult population that is a candidate for liver transplantation (LT) at the Hospital La Fe Valencia (Spain). The study is structured in three phases: I) Prehabilitation (2 months before LT); II) Training, divided in two successive periods: Supervised training (months 3-6 after LT) and Unsupervised training (6-12 months after LT); III) Long-term follow-up (2 years after LT).

Primary outcomes are related to post-surgery evolution (morbidity and mortality, hospitalization length, etc.). As a secondary outcomes are collected those related to: functional capacity, muscle strength and quality of life.

Full description

The main objective is to study the post-surgical impact (post-S) of a Prehabilitation program on candidates for liver transplantation (LT), as well as to study the effects of posttransplant training on the clinical and functional evolution of the recipients. Also this project pretends to assess the influence of functional capacity (FC) improvement on the short and long term post-S evolution of the LT candidates. This is a prospective randomized clinical trial in which three phases follow: Prehabilitation, training and follow-up. The sample will be constituted by 60 candidates for LT, randomized in a control group (CG, n=20), a Prehabilitation group (PG, n=20) and a Prehabilitation-posttransplant training group (PTG, n=20). To conventional care, a Prehabilitation program will be added to the PG and PTG. After the LT, just PTG will follow a posttransplant training program. The long-term follow-up will be extended to 2 years post-LT. The variables under study will be: complications and post-S evolution; FC; quality of life; etc. The individualization of Prehabilitation and posttransplant training program, and also medical control, will ensure safety and offer the potential benefits that these types of programs can provide.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication of elective liver transplant with favorable cardiorespiratory evaluation that does not contraindicate the transplant.

Exclusion criteria

• Any orthopedic, motor, functional, neurological, cognitive or linguistic limitation that prevents the realization of the Prehabilitation program
• Inability to perform psychometric tests
• Esophageal varices not treated with ligature or beta-blockers
• Varicose veins with a high risk of digestive hemorrhage
• Hemoglobin <80 g/l
• Contraindication to weight loading
• Impossibility to comply with the Prehabilitation program (hospital admission, work, geographical location)
• Multi-organ transplantation and liver retransplantation
• Refusal or lacks capacity to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control group

No Intervention group

Description:

Conventional medical care

Prehabilitation group

Experimental group

Description:

Conventional medical care and 8 weeks of a Prehabilitation supervised program

Treatment:

Other: Prehabilitation

Prehabilitation and posttransplant training group

Experimental group

Description:

Conventional medical care, 8 weeks of a Prehabilitation supervised program and a posttransplant training program.

Treatment:

Other: Prehabilitation

Other: Prehabilitation and posttransplant training program