Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Korean modified Barthel Index (K-MBI) at 6 months after onset
研究概览
简要总结
Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute first-ever stroke patients less than 7 days after onset
- •more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI
- •body mass index (BMI) <25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment < 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment < 85 at 7 days after stroke onset
排除标准
- •Transient ischemic stroke
- •Progressive or unstable stroke
- •Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.
- •Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.)
- •A terminal medical diagnosis consistent with survival < 1 year
- •Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)
研究组 & 干预措施
Intensive nutrition group
Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks
干预措施: Omapone Peri 724mL or Winuf Peri 654mL (Drug)
结局指标
主要结局
Korean modified Barthel Index (K-MBI) at 6 months after onset
时间窗: 6 months after onset
Korean modified Barthel Index (0\~100)
次要结局
未报告次要终点
研究者
Won Hyuk Chang
Associate Professor
Samsung Medical Center