Effects of Supervised Exercise on Rheological Functions of Erythrocyte in Patients With End-Stage Renal Disease on Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Aggregation of erythrocytes
研究概览
简要总结
To improve aerobic capacity, muscular function, and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise at moderate intensity is a viable approach to ensure patient safety, maintain compliance, and effectively enhance physiological adaptations. However, the impact of exercise training on erythrocyte rheological properties in ESRD patients, such as red blood cell deformability, aggregation, and oxygen transport capacity, remains unclear.
Method: ESRD patients (anticipated n=180) will undergo supervised exercise training therapy three times per week for six months in the hospital, followed by three months at home. Cardiopulmonary exercise tests will be conducted before and after the intervention. Erythrocyte deformability and aggregation will be assessed using a laser-assisted optical rotational cell analyzer (LORCA), while additional protein levels and reactive oxygen species (ROS) status will be measured using a flow cytometer. This will help determine how exercise affects the rheological properties of red blood cells in this population.
详细描述
Renal dysfunction often stems from cardiovascular-related comorbidities or metabolic disorders, leading to the accumulation of excessive inflammatory products or damaging the bioenergetic health of red blood cells. This eventually contributes to the development of chronic kidney disease (CKD). At the most advanced stage, known as end-stage renal disease (ESRD), patients suffer from severe uremia and renal failure, necessitating renal replacement therapy, typically in the form of dialysis.
Hemodialysis (HD) is the most common treatment for ESRD patients, especially in Taiwan, which has the highest global prevalence of HD due to related chronic diseases and a comprehensive National Health Insurance program. However, long-term maintenance HD is associated with physical inactivity and a low quality of life. As a result, exercise training is recommended to improve physiological adaptations and enhance functional capacity in HD patients. Supervised intradialytic exercise in clinical settings offers a safer and more progressive approach, leading to low dropout rates and better compliance.
Red blood cell dysfunction is a significant issue in ESRD, as impaired red blood cells can affect their deformability, aggregation, and oxygen transport capacity.
The purpose of this study is to establish reliable measurements of red blood cell function in HD patients and assess cardiovascular and muscular fitness, along with the effects of intradialytic exercise on these parameters.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Receiving hemodialysis and medication at least for 6 weeks
- •Kt/V score > 1.2
排除标准
- •Under 20 years-old
- •Hyperkalemia occurs within 3 month
- •Having orthopedic or muscular diseases
- •Other concerned medical, psychological or physiological diseases
- •Pregnancy
- •Other exercise contraindications
研究组 & 干预措施
Control group
Supervised exercise training
干预措施: Supervised exercise training (Behavioral)
结局指标
主要结局
Aggregation of erythrocytes
时间窗: 9 months
Erythrocyte aggregation is the reversible clumping of red blood cells (RBCs) under low shear forces or at stasis.
Deformability of erythrocytes
时间窗: 9 months
Red blood cells (RBCs) deformability refers to the cells' ability to adapt their shape to the dynamically changing flow conditions so as to minimize their resistance to flow.
次要结局
- Quality of life in ESRD patients(9 months)
- Cardiopulmonary fitness(9 months)
研究者
Jong-Shyan Wang
Professor
Chang Gung Memorial Hospital