Prehabilitation and Posttransplant Training Program in Liver Transplantation

NCT04246970 | Enrolling By Invitation

• 1 other identifier: 2019/0227
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prehabilitation; Therapeutic Exercise; Functional capacity

Outcome Measures

Primary Outcomes (5)

• Morbidity

  Registry of post-surgical complications according to the Clavien-Dindo classification. Reference: Ann Surg 2004; 240(2):205-13.

  The groups will be assessed from the hospitalization up to 24-months.

• Mortality

  Registry of mortality

  The groups will be assessed from the hospitalization until the date of death, assessed up to 24-months.

• Number of hospitalization days

  Registry of number of days of hospitalization in intensive care unit and ward.

  The groups will be assessed during hospitalization, approximately 7 days.

• Number of days with supplementary oxygen therapy and/or mechanical ventilation

  Registry of number of days

  The groups will be assessed during hospitalization, approximately 7 days.

• Progression in the activities of daily life (ADL)

  Days of acquisition, sitting, walking and stairs

  The groups will be assessed during hospitalization, approximately 7 days.

Secondary Outcomes (7)

• Change in functional capacity: measurement of oxygen uptake

  The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.

• Change in functional capacity: 6-minutes walking test (6MWT)

  The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.

• Change in peripheral muscle strength: handgrip strength, quadriceps femoris strength and biceps brachii strength

  The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.

• Change in respiratory strength: maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

  The groups will be assessed at baseline and at week 8.

• Change in performance on the Short Physical Performance Battery (SPPB)

  The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.

Study Arms (3)

Control group

NO INTERVENTION

Conventional medical care

Prehabilitation group

EXPERIMENTAL

Conventional medical care and 8 weeks of a Prehabilitation supervised program

Other: Prehabilitation

Prehabilitation and posttransplant training group

EXPERIMENTAL

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

Other: Prehabilitation; Other: Prehabilitation and posttransplant training program

Interventions

Prehabilitation OTHER

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.

Also known as: Interval aerobic exercise, peripheral and respiratory muscle training, balance exercise

Prehabilitation and posttransplant training group; Prehabilitation group

Prehabilitation and posttransplant training program OTHER

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).

Also known as: Interval aerobic exercise, peripheral muscle training and balance exercise

Prehabilitation and posttransplant training group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria dels Angels Cebria i Iranzo, PT, PhD: lead
• University of Valencia: collaborator

Study Sites (1)

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

Related Publications (4)

• Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

  PMID: 28489682 BACKGROUND

• Brustia R, Savier E, Scatton O. Physical exercise in cirrhotic patients: Towards prehabilitation on waiting list for liver transplantation. A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2018 Jun;42(3):205-215. doi: 10.1016/j.clinre.2017.09.005. Epub 2017 Nov 20.

  PMID: 29162460 BACKGROUND

• Debette-Gratien M, Tabouret T, Antonini MT, Dalmay F, Carrier P, Legros R, Jacques J, Vincent F, Sautereau D, Samuel D, Loustaud-Ratti V. Personalized adapted physical activity before liver transplantation: acceptability and results. Transplantation. 2015 Jan;99(1):145-50. doi: 10.1097/TP.0000000000000245.

  PMID: 25531893 BACKGROUND

• Williams FR, Vallance A, Faulkner T, Towey J, Durman S, Kyte D, Elsharkawy AM, Perera T, Holt A, Ferguson J, Lord JM, Armstrong MJ. Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. Liver Transpl. 2019 Jul;25(7):995-1006. doi: 10.1002/lt.25442. Epub 2019 Jun 6.

  PMID: 30859755 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular

Interventions

Preoperative Exercise; Breathing Exercises

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Maria A Cebrià i Iranzo, PT, PhD

  Hospital Universitari i Politècnic La Fe, Valencia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director research

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 29, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)