Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diameter of the Artery - Brachial & Radial
研究概览
简要总结
This study will investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, Pre and Post Arteriovenous Fistula Formation as well as the suitability of Cannulation of Arteriovenous Fistula at 12 weeks Post Surgery.
This is a randomised control study with 20 patients each in the Control arm (Group A) or the Exercise arm (Group B). The subjects will be randomised into 1:1 into one of the two groups.
The patients will have an ultrasound doppler vein mapping done prior surgery and the necessary follow up visits.
详细描述
The incident and prevalent population on renal replacement therapy for End Stage Renal Disease (ESRD) is steadily increasing in Singapore as well as other countries worldwide. Around 85 - 90% of the prevalent dialysis population is on Hemodialysis and Arteriovenous Fistula (AVF).
AVF is considered the Gold standard for safe and effective vascular access for hemodialysis treatment due to its low rates of complication. However, Primary Failure rate of AVFs remain high at around 20 - 25% depending on the site of the surgery, contributed by several factors including the diameter of the artery and the vein used for AVF formation.
If Pre-operative exercise improves the hemodynamics of the AVF and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of AVF.
Even though, there is sufficient evidence to support the beneficial role of the forearm exercises on fistula blood flow and maturation, there are no studies looking at the effects of Pre-Operative Exercise on AVF maturation. Our Study is aiming to fulfil this gap in knowledge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=21 to <=
- •Chronic Kidney Failure patients with Estimated Glomerular Filtration Rate (eGFR) less than 20mls/min.
- •Haemodialysis is chosen as their modality of renal replacement therapy.
排除标准
- •Potential fistula vein diameter <= 3mm (with application of tornique) on initial vein mapping.
- •Known Left ventricular ejection fraction of less than 20% on Echo diagram.
- •Previous stroke effecting the AVF arm.
- •Calcified brachial or radial arteries and/or duplex evidence of stenosis of >= 50%
结局指标
主要结局
Diameter of the Artery - Brachial & Radial
时间窗: Baseline
Measure with the use of an Ultrasound Doppler
Diameter of the Artery used for AVF
时间窗: 1 Week Pre-Op
Measure with the use of an Ultrasound Doppler
Diameter of the artery 2cm above anastomosis
时间窗: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Change of Blood Flow Rate in the Artery
时间窗: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis
时间窗: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Suitability for Cannulation
时间窗: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint
时间窗: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
次要结局
未报告次要终点