Effects of N-acetylcysteine on Muscle Fatigue in ESRD
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in quadriceps muscle endurance during intermittent submaximal contractions
研究概览
简要总结
The purposes of the study are to determine whether oxidative stress causes the muscle of dialysis patients to tire more quickly than muscle of people without kidney disease and to determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle endurance.
详细描述
Muscle dysfunction is a major problem for patients with end-stage renal disease (ESRD). Specifically, these patients experience approximately three-fold greater muscle fatigue of the lower extremities during intermittent submaximal contractions than healthy control subjects. Thus, a treatment that could ameliorate muscle fatigue in this population has the potential to increase endurance during activities of daily living and improve quality of life. Dialysis patients have been shown to have high levels of various markers of oxidative stress, and oxidative stress has been associated with excessive muscle fatigue in other patient populations, but this link has not been established in the ESRD population.
Comparisons: The amount of muscle fatigue during intermittent submaximal quadriceps exercise between dialysis patients and controls will be compared. In addition, the degree of exercise-induced increase in markers of oxidative stress in muscle and in plasma will be compared between dialysis patients and controls and between dialysis patients who have received N-acetylcysteine for 6 days and those who have received placebo capsules.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age greater than 18 years
- •undergoing hemodialysis for 3 months or more or healthy control without kidney disease
排除标准
- •inability to give informed consent
- •diagnosis of diabetes mellitus
- •musculoskeletal contraindication to exercise
- •infection requiring intravenous antibiotics within 2 months
- •hospitalization within 2 months
- •ingestion of antioxidant supplements within one month
- •requirement for systemic anticoagulation
- •estimated GFR <60 ml/min/1.73 m2 for healthy controls
结局指标
主要结局
change in quadriceps muscle endurance during intermittent submaximal contractions
时间窗: 6 days
change in exercise-induced markers of oxidative stress
时间窗: 8 days
次要结局
未报告次要终点