Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cirrhosis, Liver
  • Hepatic Carcinoma
  • Liver Transplant, Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04246970
Collaborators
University of Valencia
Investigators
Principal Investigator: Maria A Cebrià i Iranzo, PT, PhD Hospital Universitari i Politècnic La Fe, Valencia Study Chair: David Calatayud Mizrahi, MD, PhD Hospital Universitari i Politècnic La Fe, Valencia Study Chair: Natalia Cezón Serrano, PT University of Valencia Study Chair: Luis Compte Torrero, MD, PhD Hospital Universitari i Politècnic La Fe, Valencia Study Chair: Laura Arjona Tinaut, PT University of Valencia Study Chair: Rafael López Andújar, MD, PhD Hospital Universitari i Politècnic La Fe, Valencia Study Chair: Martín Prieto Castillo, MD, PhD Hospital Universitari i Politècnic La Fe, Valencia