NCT04246970

Prehabilitation and Posttransplant Training Program in Liver Transplantation

Effects of a Prehabilitation Program in Liver Transplant Candidates Followed by a Posttransplant Training Program

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Maria dels Angels Cebria i Iranzo, PT, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-04-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-01-29
• Last updated: 2025-09-15

Locations

1 site across 1 country: Spain