Effects of a Prehabilitation Program in Liver Transplant Candidates Followed by a Posttransplant Training Program
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Morbidity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of elective liver transplant with favorable cardiorespiratory evaluation that does not contraindicate the transplant.
排除标准
- •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
结局指标
主要结局
Morbidity
时间窗: 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
时间窗: The groups will be assessed during hospitalization, approximately 7 days.
Registry of number of days of hospitalization in intensive care unit and ward.
Mortality
时间窗: 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
时间窗: The groups will be assessed during hospitalization, approximately 7 days.
Registry of number of days
Progression in the activities of daily life (ADL)
时间窗: The groups will be assessed during hospitalization, approximately 7 days.
Days of acquisition, sitting, walking and stairs
次要结局
- 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 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.)
- 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.)
- 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 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.)
- 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.)
研究者
Maria dels Angels Cebria i Iranzo, PT, PhD
Director research
Hospital Universitario La Fe