NCT05061576招募中不适用
Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in quality of life summary score, as measured with the CLDQ tool
研究概览
简要总结
The study will compare two forms of advice regarding physical activity for patients hospitalized with cirrhosis that are preparing for leaving the hospital. One arm consists of current standard of care: simple oral advice on exercise. One arm instead gives patients a structured but simple paper template on physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Liver cirrhosis diagnosed with previous clinical assessment and radiology (de-formed liver, noduli, varices, collaterals, splenomegaly >12 cm) or with biopsy (fibrosis grade 4). ICD-code K70.3, K74.
- •MELD < 25
- •Understanding the Swedish language.
- •Signed informed consent.
排除标准
- •Performance status ≥
- •Severe pain which prevents the patient to perform the physical activities, as judged by the attending physician at time of discharge.
- •Previously liver transplanted
- •Unlikely to be compliant to follow-up (living in other parts of Sweden), as judged by the attending physician at time of discharge.
结局指标
主要结局
Change in quality of life summary score, as measured with the CLDQ tool
时间窗: 3 months
Change in quality of life, as measured with the CLDQ tool (gives a summary score between 1-7, a higher score suggests a better quality of life).
次要结局
- Mortality(3 months)
- MELD(3 months)
- Frailty(3 months)
研究者
Hannes Hagström
Principal Investigator
Karolinska University Hospital
研究点 (2)
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