Prehabilitation and Posttransplant Training Program in Liver Transplantation
- Conditions
- Hepatic CarcinomaLiver Transplant; ComplicationsCirrhosis, Liver
- Interventions
- Other: PrehabilitationOther: Prehabilitation and posttransplant training program
- Registration Number
- NCT04246970
- Lead Sponsor
- Maria dels Angels Cebria i Iranzo, PT, PhD
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- Indication of elective liver transplant with favorable cardiorespiratory evaluation that does not contraindicate the transplant.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation group Prehabilitation Conventional medical care and 8 weeks of a Prehabilitation supervised program Prehabilitation and posttransplant training group Prehabilitation Conventional medical care, 8 weeks of a Prehabilitation supervised program and a posttransplant training program. Prehabilitation and posttransplant training group Prehabilitation and posttransplant training program Conventional medical care, 8 weeks of a Prehabilitation supervised program and a posttransplant training program.
- Primary Outcome Measures
Name Time Method 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.
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.
Mortality The groups will be assessed from the hospitalization until the date of death, assessed up to 24-months. Registry of mortality
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
- Secondary Outcome Measures
Name Time Method Change in respiratory strength: maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) The groups will be assessed at baseline and at week 8. Maximum respiratory pressures will be measured using a Respiratory Pressure Meter MicroRPM® and the unit of measure is cmH2O. MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535
Change in muscle mass The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT. Bioelectrical impedance analysis will be completed using the Bodystat 1500 MDD, which is a multi-frequency body composition analyzer. Body fat percentage (%) will be compared to lean body mass percentage and total body water percentage to assess sarcopenia and nutritional status.
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. The SPPB is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines three areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. Static balance is measured in units of time (seconds) and patients are timed holding 3 different stances. Gait speed is measured in time (seconds) to walk 4 meters. Chair sits are measured as the time (seconds) it takes to get up and out of a chair 5 times without using one's arms to assist the exercise. Collectively, the three tests are used to generate a total score (0-12) that reflects a patient's frailty (score of 0) or lack of frailty (score of 12). Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49:M85-M94.
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. 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis. American Thoracic Society (ATS) Statement Guidelines for the Six-Minute Walk Test. Am J Resp Crit Care Med 2002;166(1):111-117
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. Isometric peripheral muscle strength will be measured using a digital hand dynamometer and the unit of measure is kilograms. References:
Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall CC, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age and Ageing 2011;40(4):423-9.
Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996; 76(3):248-59Change in Quality of life The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT. Short-Form Liver Disease Quality of Life (SF-LDQOL) is formed by 9 dimensions: symptoms of the disease, effects of the disease on the activities of daily life, memory/concentration, anxiety, sleep, loneliness, hopelessness, stigma for the disease and sexual functioning. The minimum and maximum values of the scale are 0-100, so that the higher the score, the better health related quality of life (HRQL).
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. Cardiopulmonary exercise test following an incremental protocol on ramp with a bicycle ergometer.
Trial Locations
- Locations (1)
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain