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临床试验/NCT07238855
NCT07238855已完成不适用

Effect of Isometric Hand Grip Exercises Using a Dynamometer on Arteriovenous Fistula Maturation and Patency in Hemodialysis Patients

Mansoura University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Change in arteriovenous fistula blood flow volume measured by Doppler ultrasound

研究概览

简要总结

Patients with chronic kidney failure who require hemodialysis depend on a surgically created connection between an artery and a vein in the arm, known as an arteriovenous fistula. This connection allows blood to flow at a high enough rate for effective hemodialysis treatment. However, many arteriovenous fistulas do not enlarge or strengthen adequately after surgery, a process known as maturation. When maturation fails, the fistula may not provide enough blood flow, leading to delays in hemodialysis, repeated procedures, or the need for temporary catheters. Improving the maturation of arteriovenous fistulas is therefore essential for patient safety, comfort, and the long-term success of hemodialysis.

Isometric hand-grip exercises, such as repeatedly squeezing a hand-held dynamometer, may help increase blood flow to the arm and stimulate the blood vessels that are part of the fistula. These exercises require the muscles to contract without changing length, which can encourage enlargement of the vein and the development of new small blood vessels in the forearm. Previous research suggests that improving hand-grip strength may support better vein remodeling and improved blood flow, both of which are important for fistula maturation.

This study is designed to evaluate whether performing a structured program of isometric hand-grip exercises using a dynamometer can enhance the maturation and long-term openness (patency) of arteriovenous fistulas in adults receiving hemodialysis. Participants are randomly assigned to one of two groups: a control group that receives routine postoperative care, and an exercise group that performs hand-grip exercises for six weeks. All participants undergo ultrasound imaging of the fistula before starting the study and again after six weeks. The ultrasound measurements include fistula size, vein diameter, blood flow, and blood flow velocity.

The goal of this study is to determine whether a simple, low-cost exercise intervention can help arteriovenous fistulas mature more successfully and reduce the need for additional procedures.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18 to 75 years
  • •End-stage renal disease requiring hemodialysis
  • •Patients undergoing hemodialysis through a surgically created arteriovenous fistula
  • •Ability to provide written informed consent

排除标准

  • •Failure or refusal to provide written informed consent
  • •Amputation of the arm or fingers
  • •Significant osteoarthritis of the hand or wrist
  • •Severe physical disability preventing exercise performance
  • •Active infection or ongoing hospitalization
  • •Known underlying malignancy

研究组 & 干预措施

Control Group - Standard Postoperative Care

No Intervention

Participants in this arm receive the standard postoperative care provided after the creation of an arteriovenous fistula for hemodialysis. They do not perform any structured exercise program. Routine follow-up assessments, including Doppler ultrasound evaluation of fistula diameter, blood flow, and blood flow velocity, are conducted at baseline and after six weeks.

Hand-Grip Exercise Group - Isometric Training With Dynamometer

Experimental

Participants in this arm receive standard postoperative care plus a structured isometric hand-grip exercise program using a hand-held dynamometer. The intervention consists of adjusting the dynamometer grip to hand size, positioning the arm at a ninety-degree angle, and performing three maximal-effort squeezes repeated to calculate average grip strength. Exercises are performed regularly for six weeks. Doppler ultrasound measurements of fistula diameter, vein caliber, blood flow, and blood flow velocity are obtained at baseline and after six weeks to evaluate maturation and patency.

干预措施: Isometric Hand-Grip Exercise Training Using a Hand Dynamometer (Behavioral)

结局指标

主要结局

Change in arteriovenous fistula blood flow volume measured by Doppler ultrasound

时间窗: Baseline and six weeks after starting the hand-grip exercise program or standard care

Blood flow volume through the arteriovenous fistula (milliliters per minute) will be measured using duplex Doppler ultrasound at the outflow vein. The primary metric is the change in blood flow volume from baseline (before starting the hand-grip exercise program or standard care) to six weeks. Change will be calculated as the value at six weeks minus the baseline value for each participant.

次要结局

  • Change in arteriovenous fistula vein diameter measured by Doppler ultrasound(Baseline and six weeks after starting the hand-grip exercise program or standard care)
  • Change in hand-grip muscle strength of the dominant hand(Baseline and six weeks after starting the hand-grip exercise program or standard care)
  • Clinical usability of the arteriovenous fistula for hemodialysis(Assessed at six weeks after starting the hand-grip exercise program or standard care)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Zidan

Resident of Internal Medicine and Nephrology

Mansoura University

研究点 (1)

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