NCT06231420Enrolling By Invitation不适用
Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group.
研究概览
简要总结
The goal of clinical trial is to compare using pedometer in sarcopenic cirrhotic patients. The main questions it aims to answer are:
- Did the encourage using pedometer group had higher change of skeletal muscle index (SMI) than discourage using pedometer group?
- How many of patients who had sarcopenic improvement in both groups at 6 months after enrollment?
- What is the mortality rate and hospital admission in both groups at 12 months after enrollment?
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years old
- •Cirrhotic patient with diagnosed sarcopenia
- •Patients or caregiver who can write and announce Thai language
- •Cirrhotic patient who was post liver transplantation > 1 year
排除标准
- •Cirrhosis Child-Turcotte-Pugh (CTP) C > 10
- •Refractory ascites
- •Decompensated comorbidity: heart failure NYHA III-IV, ESRD with dialysis, COPD Gold D
- •Performance status ECOG 3-4
- •Bone fracture within 4 weeks or limitation of activity
- •Pregnancy and breastfeeding
- •HCC during treatment with TACE or microwave ablation or radiofrequency ablation within 6 months before enrollment
- •Advanced stage malignancy
- •Received chemotherapy
- •Muscle weakness disease
- •Recent cerebrovascular disease within 6 months and motor weakness grade < II
- •Age 65-75 years old with history of falling > 2 times/year
结局指标
主要结局
To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group.
时间窗: 6 months
Change of skeletal muscle index (SMI) between both groups.
次要结局
- The hospital admission(12 months)
- Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group.(6 months)
- Mortality rate in encourage using pedometer group and discourage using pedometer group.(12 months)
研究者
Watcharasak Chotiyaputta
Associate professor, Faculty of Medicine Siriraj Hospital
Mahidol University
研究点 (2)
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