Prehabilitation and Posttransplant Training Program in Liver Transplantation

Summary

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.

Conditions

• Liver Transplant; Complications
• Cirrhosis, Liver
• Hepatic Carcinoma

Interventions

OTHER

Prehabilitation

Supervised training program of 8-weeks and a frequency of 2 days/week. It includes interval aerobic exercise (5 cycles of 2 minutes at 70 percentage of Watts or heart rate of cardiopulmonary exercise testing (CEPT) and 3 minutes of active rest at 40 percentage; peripheral muscle training and balance exercises in a circuit of 10 phases, 10 to 15 repetitions, from 1 to 3 sets (the participants will work at moderate intensity, no more than 5-6/10 on the modified Borg scale); Inspiratory Muscle Training (IMT) through a threshold loading device \[2 sessions / day, 3 sets of 15 repetitions, at 60-70 percentage of the maximum inspiratory pressure (cmH2O)\]; ventilatory reeducation by an incentive inspirator based on the vital capacity evaluated in the initial spirometry. Both the aerobic modality and the resistance training, will increase the intensity of work (HR, Watts, Kg or cmH2O) between 2-5 percentage every 2 weeks complying with the principle of training overload.

OTHER

Prehabilitation and posttransplant training program

Prehabilitation will be followed by a posttransplant training program. In this, the patient will perform supervised exercise (IIa interval aerobic exercise and resistance training) 2 days / week, and a physical exercise program at home until completing a total of 5 sessions / week in the aerobic modality. In the unsupervised phase (IIb), the patient will continue with the learned physical exercise program, but without supervision, 5 sessions / week (including a minimum of 2 non-consecutive sessions to perform resistance training).

Sponsors & Collaborators

• University of Valencia

  collaborator OTHER

• Maria dels Angels Cebria i Iranzo, PT, PhD

  lead OTHER

Principal Investigators

• Maria A Cebrià i Iranzo, PT, PhD · Hospital Universitari i Politècnic La Fe, Valencia

• David Calatayud Mizrahi, MD, PhD · Hospital Universitari i Politècnic La Fe, Valencia

• Natalia Cezón Serrano, PT · University of Valencia

• Luis Compte Torrero, MD, PhD · Hospital Universitari i Politècnic La Fe, Valencia

• Laura Arjona Tinaut, PT · University of Valencia

• Rafael López Andújar, MD, PhD · Hospital Universitari i Politècnic La Fe, Valencia

• Martín Prieto Castillo, MD, PhD · Hospital Universitari i Politècnic La Fe, Valencia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Spain

Study Locations