A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Quantify toxin removal
研究概览
简要总结
Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it is suggested that exercise increases the cardiac output, thus increases the blood flow to lower extremities. This leads to increased toxin removal from low blood flow regions. On the other hand, exercise can possibly dilate the vasculature and decrease the compartmental resistance. In this study, the investigators aim to investigate the exercise induced physiological changes which enhances the toxin removal. This information combined with patient specific mathematical models will encourage clinicians to opt for Optimal intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients male or female (Age > 21 years)
- •Minimum dialysis vintage of 6 months
- •Stable on hemodialysis
- •Minimum Hemoglobin level of 10 g/dL
- •Blood access capable of delivering the blood flow rate greater than 250 mL/min
- •Preserved left ventricular ejection fraction (>50%) on prior imaging study
- •Able to complete a 6min-walk-test without abnormal physiological response, excessive fatigue, or musculoskeletal discomfort
排除标准
- •History of recurring or persistent hypotension in past 3 months
- •Pregnant woman
- •Severely Hypertensive patients (SBP > 180 mmHg and/or DBP > 115 mmHg)
- •History of recent myocardial infarction or unstable angina (within past 6 months)
- •Significant valvular disease, i.e. severe aortic stenosis and moderate-severe mitral regurgitation.
- •Patients with end stage organ disease e.g. COPD, recent or debilitating CVA
- •Patient with recent stroke (within past 6 months)
- •Anemic patients
- •History of known arrhythmia
- •Participation in another clinical intervention trial
- •Moderate to severe osteoarthritis of knee(s)
- •Unable to consent
研究组 & 干预措施
HD-Exercise-HDF
Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.
干预措施: Intra-dialytic exercise (Procedure)
结局指标
主要结局
Quantify toxin removal
时间窗: 6 months
Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes
次要结局
- Compare exercise regimen with HDF(6 months)