Effect of a 3-month Aerobic Training Program on Endothelial Function in Mild-to-moderate CKD: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)
研究概览
简要总结
Chronic kidney disease (CKD) is a prevalent disorder and a major health concern. Cardiovascular disease is the most prevailing and life-threatening complication observed in patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are more likely to occur than the evolution to final stages of kidney disease with the need for dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not affect cardiovascular prognosis in CKD, which suggests that the missing link between these two entities has not been elucidated yet.
In the present project, the investigators focus on endothelial dysfunction in patients with CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the absence of structural changes, endothelial dysfunction is still reversible, which offers therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage.
The purpose of this study is to determine whether an exercise training program is effective in ameliorating endothelial dysfunction in patients with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- 否
入选标准
- •patients with CKD stage 3-4 (eGFR (15-59 ml/min/1.73m2) without cardiovascular disease.
排除标准
- •patients < 18 years
- •pregnancy
- •warfarin therapy
- •glucocorticoid therapy
- •clinically active malignant disease
- •heart failure (ejection fraction < 50%)
- •peripheral vascular disease, defined as a history of intermittent claudication, abnormal peripheral angiography or Doppler ultrasound, lower limb artery bypass surgery/angioplasty/stenting or non-traumatic lower extremity amputation
- •cerebrovascular disease, defined as a history of transient ischemic attack (TIA) or stroke, significant stenosis of the A. carotis on ultrasound/CT angiography or carotid endarterectomy/stenting
- •coronary artery disease (CAD), defined as a history of myocardial infarction, coronary artery angioplasty/stenting/bypass surgery, significant structural coronary lesions on angiography or high suspicion of CAD on a maximal exercise test
研究组 & 干预措施
Usual Care
Exercise Training
干预措施: Exercise Training (Behavioral)
结局指标
主要结局
Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)
时间窗: 3 months
次要结局
- change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity(3 months)
- change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness(3 months)
- change in augmentation index (%) as a marker of arterial stiffness(3 months)
- change in Intima Media Thickness (µm) of the right common carotid artery(3 months)
研究者
Amaryllis Van Craenenbroeck
Dr.
Universiteit Antwerpen