Clinical trial NCT04246970: Prehabilitation and Posttransplant Training Program in Liver Transplantation
Official title: Effects of a Prehabilitation Program in Liver Transplant Candidates Followed by a Posttransplant Training Program
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Liver Transplant; Complications
Cirrhosis, Liver
Hepatic Carcinoma
Keywords: Prehabilitation
Therapeutic Exercise
Functional capacity
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2020-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity
timeFrame: The groups will be assessed from the hospitalization up to 24-months.
measure: Mortality
timeFrame: The groups will be assessed from the hospitalization until the date of death, assessed up to 24-months.
measure: Number of hospitalization days
timeFrame: The groups will be assessed during hospitalization, approximately 7 days.
measure: Number of days with supplementary oxygen therapy and/or mechanical ventilation
timeFrame: The groups will be assessed during hospitalization, approximately 7 days.
measure: Progression in the activities of daily life (ADL)
timeFrame: The groups will be assessed during hospitalization, approximately 7 days.
Secondary outcomes:
measure: Change in functional capacity: measurement of oxygen uptake
timeFrame: The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.
measure: Change in functional capacity: 6-minutes walking test (6MWT)
timeFrame: The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.
measure: Change in peripheral muscle strength: handgrip strength, quadriceps femoris strength and biceps brachii strength
timeFrame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
measure: Change in respiratory strength: maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
timeFrame: The groups will be assessed at baseline and at week 8.
measure: Change in performance on the Short Physical Performance Battery (SPPB)
timeFrame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
measure: Change in muscle mass
timeFrame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
measure: Change in Quality of life
timeFrame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Hospital Universitari i Politècnic La Fe, Valencia
name: Maria A Cebrià i Iranzo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari i Politècnic La Fe, Valencia
name: David Calatayud Mizrahi, MD, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Natalia Cezón Serrano, PT
role: STUDY_CHAIR
affiliation: Hospital Universitari i Politècnic La Fe, Valencia
name: Luis Compte Torrero, MD, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Laura Arjona Tinaut, PT
role: STUDY_CHAIR
affiliation: Hospital Universitari i Politècnic La Fe, Valencia
name: Rafael López Andújar, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitari i Politècnic La Fe, Valencia
name: Martín Prieto Castillo, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.