Prehabilitation and Posttransplant Training Program in Liver Transplantation

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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).

Study 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.

Eligibility

Primary outcome measure(s)

• Morbidity — The groups will be assessed from the hospitalization up to 24-months.
  Registry of post-surgical complications according to the Clavien-Dindo classification. Reference: Ann Surg 2004; 240(2):205-13.
• Mortality — The groups will be assessed from the hospitalization until the date of death, assessed up to 24-months.
  Registry of mortality
• Number of hospitalization days — The groups will be assessed during hospitalization, approximately 7 days.
  Registry of number of days of hospitalization in intensive care unit and ward.
• Number of days with supplementary oxygen therapy and/or mechanical ventilation — The groups will be assessed during hospitalization, approximately 7 days.
  Registry of number of days
• Progression in the activities of daily life (ADL) — The groups will be assessed during hospitalization, approximately 7 days.
  Days of acquisition, sitting, walking and stairs

Trial sites (1)

Other trials for the same condition