The Impact of Exercise on Vascular Remodeling, Arteriovenous Fistula Creation and Use in Patients With Chronic Kidney Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Late dialysis suitability failure
研究概览
简要总结
The purpose of this research study is to determine whether two different types of forearm exercise, performed before fistula creation surgery, can improve surgery success and fistula maturation.
详细描述
This is a randomized, double blinded controlled trial to study the impact of handgrip exercise prior to surgical creation of hemodialysis fistula on vascular remodelling and fistula maturation in chronic kidney disease 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
- Double (Care Provider, 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
- •Adult (age>18 years old) with chronic kidney disease
- •Hemodialysis is their renal replacement therapy (RRT) modality
- •Deemed eligible for an arteriovenous fistula
- •Anticipated RRT start < 3 months (from the time of vascular surgery assessment) if predialysis
- •Scheduled surgical creation of fistula aniticpated >= 8 weeks
- •Able to follow instructions for an exercise intervention
- •Able to provide informed written consent
排除标准
- •Life expectancy < 6 months
- •Need for urgent vascular access (i.e. <4 weeks)
- •Pre-existing fistula distal to site of newly scheduled fistula
- •Ipsilateral central stenosis or occlusions not amenable to correction
- •Contraindications or unable to perform handgrip exercise
- •Unable to withstand transiently raised systolic blood pressure (SBP) by 35 mmHg, and diastolic (DBP) by 25 mmHg
- •severe upper extremity arthritis or other pain
- •Contraindications to general exercise
- •Poorly controlled blood pressure - SBP>180, DBP>90; SBP<110, DBP<50
- •NYHC IV heart failure
结局指标
主要结局
Late dialysis suitability failure
时间窗: 6 months after surgery
Late dialysis suitability failure is a fistula that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the sixth month following its creation.
次要结局
- Change of intra-access flow and vascular diameters at predetermined distances from the fistula anastomosis; arterial stiffness and endothelial function on a randomly determined sub sample of patients.(Baseline, week 9 and week 11)
- Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels(Baseline, week 9 and week 11)
- Fistula maturation(6 weeks after surgery)
研究者
Charmaine Lok
Professor of Medicine, University of Toronto
University Health Network, Toronto