The Effect of Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change of the cardio-ankle vascular index (CAVI) for 2 years
研究概览
简要总结
To determine the effect of intradialytic cycling exercise on fatigability, sleep disorders, arterial stiffness and endothelial function in dialysis patients
详细描述
The endothelium is a key regulator of vascular homeostasis and chronic exposure to vascular risk factors alters the regulatory properties of the endothelium, which progresses toward a pro-inflammatory pattern, senescence, and apoptosis. Endothelial cell integrity and function are critical to the prevention of atherosclerosis, and therefore endothelial cell injury and dysfunction are major steps in the development and progression of cardiovascular disease. Endothelial dysfunction may be the landmark of active disease process through the course of atherosclerotic cardiovascular disease, and a significant risk factor for future cardiovascular events.
Several studies had reported that not only medical treatment but also exercise could improve physical and vascular functions, dialytic efficiency, quality of sleep, fatigue and depression et al. Exercise could be classified to aerobic, Anaerobic exercise and resistance et. Several studies have shown that regular cycling exercise in hemodialysis patients could improve physical activity, sleep quality, and reduce fatigability. Therefore, exercise plays an important role in hemodialysis patients. According to these benefits, the investigator's study was designed to explore the effects of intradialytic cycling exercise on sleep quality and fatigability, adipokines and myokinins levels in hemodialysis patients.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Regular hemodialysis more than 3 months with 4 hours a time, thrice a week
- •Eligible to sign permit
排除标准
- •Could not sign permit or do not want to join the trial
- •Infection
- •Amputation of any one of the lower limb
- •Hemodynamic unstable
- •Acute myocardial infarction (AMI) in recent 6 months
- •Unstable heart condition, such as unstable angina, arrythmia
- •Deep vein thrombosis (DVT)
- •History of kidney transplantation
- •Vascular access over lower limb
结局指标
主要结局
Change of the cardio-ankle vascular index (CAVI) for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the CAVI before, during and after intradialytic cycling exercise CAVI is a novel and accurate method, independent of the effect of blood pressure, and is used as a predictor of arterial stiffness (AS) AS was defined as a CAVI ≥ 9
Change of the digital thermal monitoring (DTM) for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the DTM before, during and after intradialytic cycling exercise DTM is a simple noninvasive method to measure endothelial function and vascular reactivity that is correlated with atherosclerosis risk factors and coronary artery disease Vascular reactivity index (VRI) \< 1.0: the poor vascular reactivity, 1.0 ≤ VRI \< 2.0: the intermediate vascular reactivity, and VRI ≥ 2.0: the good vascular reactivity.
Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the FACIT-F score before, during and after intradialytic cycling exercise FACIT-F score is from 0-52 points; higher score represents less fatigue.
Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the PSQI score before, during and after intradialytic cycling exercise PSQI score is from 0-21 points; score\>=5 means poor sleeping quality.
Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the baPWV before, during and after intradialytic cycling exercise baPWV is one measure arterial stiffness using brachial to ankle arterial wave analyses and has been used to assess peripheral arterial stiffness (PAS) baPWV value \>14.0 m/s on either side was considered high PAS.
Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the cfPWV before, during and after intradialytic cycling exercise cfPWV measurement: a measure of aortic wall stiffness, increases markedly with age. Each set of pulse wave and ECG data to calculate the mean time difference between R-wave and pulse wave on a beat-to-beat basis, with an average of 10 consecutive cardiac cycles. The cfPWV will be calculated using the distance and mean time difference between the two recorded points. Patients with cfPWV values of \> 10 m/s were classified in the high arterial stiffness group, whereas those with cfPWV values of ≤10 m/s were assigned to the low arterial stiffness group.
Change of the aortic augmentation index(AI) measurements for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the AI before, during and after intradialytic cycling exercise AI of central blood pressure have been widely used as clinical indices of arterial stiffness AI is an indirect measure of central arterial stiffness, but mainly a direct measure of central wave reflection
Change of the brachial flow-mediated vasodilatation (bFMD) for 2 years
时间窗: pre-test and then every 3 months for 2 years
Compare the bFMD before, during and after intradialytic cycling exercise Endothelial function is often quantified by FMD, which represents the endothelium-dependent relaxation of a conduit artery-typically the brachial artery - due to an increased blood flow.
次要结局
未报告次要终点