NCT00179140已完成2 期
The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- increase in lean body mass
研究概览
简要总结
The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
- •Adequately dialyzed (Kt/V > 1.4).
- •Age > 18 years old.
- •Properly functioning AV Graft
排除标准
- •Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc.
- •Pregnant women.
- •Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
- •Patients hospitalized within the last month prior to the study.
- •Patients will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.
研究组 & 干预措施
2
Active Comparator
protein supplementation plus resistance exercise
干预措施: nutritional supplementation (Drug)
3
Active Comparator
protein supplementation only
干预措施: nutritional supplementation (Drug)
3
Active Comparator
protein supplementation only
干预措施: exercise (Behavioral)
结局指标
主要结局
increase in lean body mass
时间窗: 13 months
次要结局
- improve physical functioning(13 months)
研究者
Alp Ikizler
Professor
Vanderbilt University
研究点 (1)
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