The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Modified Barthel Index (MBI) Score at 6 Months
研究概览
简要总结
The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.
详细描述
Elderly patients, including those who have had a stroke, are more at risk of undernutrition than other groups because of reduced nutritional reserves, prolonged hospital stay and increased demands of repeated ill-health. Stroke may compound these problems because of physical and mental incapacity, problems with perception and communication, and swallowing disorders. The full extent of undernutrition and its independent contribution to stroke outcome is not presently known. It is also not known whether it can be corrected, and whether doing so would improve the outcome. The aim of this study is therefore to describe the efficacy of Intensive Nutritional Supplement in Patient with Stroke.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 st onset stroke patient
- •MRI confirms his/her stroke
- •more than 2.5% weight los within 2 weeks
- •initial serum albumin < 35 g/l
- •BMI < 18.5
- •more than MMSE 10
- •medically stable
排除标准
- •recurrent stroke patient
- •malabsorption patient
- •terminal cancer
结局指标
主要结局
Modified Barthel Index (MBI) Score at 6 Months
时间窗: 6 months
Scale range: 0-100 (higher values represent a better outcome)
次要结局
- Chemical Laboratory Findings(6 months)
研究者
Nam-Jong Paik
professor
Seoul National University Bundang Hospital