Presurgical Arm Exercises Prior to Creation of a Forearm AV Fistula in Hemodialysis (HD) Patients With End-stage Kidney Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants with fistula usable without intervention
研究概览
简要总结
For chronic hemodialysis patients, the creation of a well-functioning arteriovenous (AV) fistula is critical for ensuring that patient receive adequate hemodialysis. Unfortunately, the primary failure rate for AV fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of pharmaceutical agents and biologic agents. A key to success in the development of a useable AV fistula is an adequate arterial and venous diameter in the access forearm. Although exercise is commonly used to increase vessel diameter after AV fistula placement, Investigators are unaware of published studies that report on the effect of exercise prior to AV fistula placement to assist with the maturation of a newly created AV fistula. In this pilot trial, the Principal Investigator will evaluate the feasibility and possible benefits of pre-surgical exercise on forearm AV fistulas.
详细描述
The trial is designed to determine if a pre-surgical exercise program will improve the likelihood of a useable forearm AV fistula. In this pilot study, the feasibility of the proposed intervention will be assessed in terms of both patient acceptability and patient outcomes. In addition, results from this feasibility study will be used to help determine power calculations for a full-scale trial.
Patients will be eligible for this pilot clinical trial if scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access. Patients will be randomized using a random number generator to either the intervention or the control group. The intervention group will be instructed in the use of hand grip with built in digital counter. These instructions will include the use of the hand grip on a daily basis with an increasing number of hand grip squeezes to be performed each week up until the time of fistula placement.
Patients in the control group will not receive any pre-surgical instructions for exercise in the access arm. In both groups, patients will be provided with post-surgical instructions on the use of a squeeze ball on a daily basis once the steri-strips from the surgical site have fallen off.
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
- None
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
- •Scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access.
排除标准
- •The presence of joint or musculoskeletal impairments that prevent the patient from using a handgrip device on a daily basis
结局指标
主要结局
Number of participants with fistula usable without intervention
时间窗: Up to 12 weeks after surgical creation of the AV fistula
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Number of participants with fistula usable with intervention
时间窗: Up to 12 weeks after surgical creation of the AV fistula
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Number of participants with fistula not usable
时间窗: Up to 12 weeks after surgical creation of the AV fistula
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
次要结局
- Mean Number of hand grips per day(Up to 8 weeks after start of the intervention)
- Mean Number of days hand grips performed(Up to 8 weeks after start of the intervention)
- Total mean number of hand grip repetitions performed(Up to 8 weeks after start of the intervention)
- Cephalic Vein Doppler measurement(Up to 8 weeks after start of the intervention)
- Basilic Vein Doppler measurement(Up to 8 weeks after start of the intervention)
- Median Cubital Doppler measurement(Up to 8 weeks after start of the intervention)
- Radial Artery Doppler measurement(Up to 8 weeks after start of the intervention)