Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
This study will assess the feasibility, safety and effectiveness of a structured prehabilitation program combining exercise training, nutritional optimization and psychological support for patients with cirrhosis awaiting liver transplantation.
详细描述
Due to their chronic liver disease, patients with cirrhosis awaiting liver transplantation develop low muscle mass, poor nutritional status and decreased reserves putting them at high risk of postoperative complications, prolonged hospital stay, and failed discharge home after liver transplantation. Prehabilitation aims to optimize a patient before they undergo a major surgery. These programs combine exercise training, with nutritional optimization and psychological support. Together, these contribute to improve their muscle mass, tolerance to exercise, and nutritional status. The current study will assess whether an individualized and structured prehabilitation program combining supervised exercise training, nutritional optimization and psychological support will benefit patients with cirrhosis awaiting liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age above 18 years
- •Diagnosis of cirrhosis, based on a combination of clinical, laboratory, imaging, or histology
- •Active on the liver transplant waiting list of the MUHC
排除标准
- •Biological Model for End Stage Liver Disease >20
- •Hepatic decompensation within the last month
- •High risk varices not on primary or secondary prevention
- •Recurrent large volume paracentesis
- •Persistent hepatic encephalopathy
- •Platelets <20,000/µL, or hemoglobin <80g/L
- •Altered hemodynamics
- •Significant heart disease
- •Awaiting combined organ transplantation
- •Awaiting repeat liver transplantation
- •Condition limiting mobilization and/or exercise, or recurrent falls
研究组 & 干预措施
Prehabilitation
Multimodal prehabilitation program
干预措施: Prehabilitation (Behavioral)
结局指标
主要结局
Feasibility of the intervention
时间窗: 12 months
Proportion of participants that adhere to the intervention protocol
次要结局
- Safety of the intervention(24 weeks)
- Impact of psychological program on health-related quality of life(At end of week-4, week 14, and week-24)
- Impact of exercise program on frailty(At end of week-4, week-14, and week-24)
- Impact of nutritional program on nutritional status(At end of week-4, week 14, and week-24)
研究者
Amine Benmassaoud
Study Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre