Exercise Intervention in Liver Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 6
- 主要终点
- Liver Frailty Index
研究概览
简要总结
The purpose of this study is to learn more about the effects of exercise on functional status and outcomes on patients with end-stage liver disease on the liver transplant waiting list and who have undergone liver transplantation.
详细描述
This study aims to evaluate the effects of a home-based exercise intervention on outcomes in liver transplant candidates and recipients. This home-based intervention consists of a 30-minute exercise session available on digital video disc or on the internet. This intervention was originally developed to improve functional status in community-dwelling older adults and therefore, has been designed to maximize the safety for even the most frail individuals. Subjects enrolled in this study will be randomized to one of two arms: (a) the exercise intervention arm in which the subjects will be asked perform this exercise session three to four times per week or (b) the standard-of-care arm in which the patient will be encouraged to exercise by their transplant clinician at every clinic visit. Subjects in the exercise intervention arm will undergo this intervention for 6 months. All subjects will be followed for up to two years from the time of enrollment to ascertain outcomes.
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
- 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
- •Adult (>=18 years of age)
- •Listed for liver transplantation or post-liver transplantation
- •English speaking
排除标准
- •Contraindications to weight-bearing exercise
- •Non-English speaking
- •Requires an assistive device for ambulation
- •Active hepatic encephalopathy at the time of baseline assessment for enrollment in the study
结局指标
主要结局
Liver Frailty Index
时间窗: 12 and 24 weeks after enrollment
Liver Frailty Index as measured by score in functional assessments of grip strength (kg), balance (seconds), and chair stands (seconds).
次要结局
- Mortality at 24 weeks(1 year)
- Hospitalized days at 24 weeks(1 year)
- Quality of Life by CLDQ(12 and 24 weeks after enrollment)