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

Overview

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.

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 Trai
• 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 sessi

Primary outcome measures

• Morbidity [Time frame: The groups will be assessed from the hospitalization up to 24-months.]
• Mortality [Time frame: The groups will be assessed from the hospitalization until the date of death, assessed up to 24-months.]
• Number of hospitalization days [Time frame: The groups will be assessed during hospitalization, approximately 7 days.]
• Number of days with supplementary oxygen therapy and/or mechanical ventilation [Time frame: The groups will be assessed during hospitalization, approximately 7 days.]
• Progression in the activities of daily life (ADL) [Time frame: The groups will be assessed during hospitalization, approximately 7 days.]

Secondary outcome measures (7)

• Change in functional capacity: measurement of oxygen uptake [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: The groups will be assessed at baseline and at week 8.]
• Change in performance on the Short Physical Performance Battery (SPPB) [Time frame: 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 muscle mass [Time frame: 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 Quality of life [Time frame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitari i Politècnic La Fe — Valencia

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT04246970 · 2019/0227

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗