Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Presurgical Arm Exercises Prior to Creation of a Forearm AV Fistula in Hemodialysis (HD) Patients With End-stage Kidney Disease: A Pilot Study

Conditions
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Arterio-venous Fistula, Kidney Failure, Hemodialysis Access Failure

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access. Exclusion Criteria: The presence of joint or musculoskeletal impairments that prevent the patient from using a handgrip device on a daily basis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized study with two arms: Intervention arm with a pre-fistula placement exercise program versus a control arm with no prefistula placement exercise
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial | Other: Exercise<br>* Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial<br>|
| No Intervention: Control<br>Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with fistula usable without intervention | 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. | Up to 12 weeks after surgical creation of the AV fistula | 
| Number of participants with fistula usable with intervention | 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. | Up to 12 weeks after surgical creation of the AV fistula | 
| Number of participants with fistula not usable | 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. | Up to 12 weeks after surgical creation of the AV fistula | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The diameter of the vessel in centimeters will be measured using a Duplex Doppler. | Up to 8 weeks after start of the intervention | 
| Basilic Vein Doppler measurement | The diameter of the vessel in centimeters will be measured using a Duplex Doppler. | Up to 8 weeks after start of the intervention | 
| Median Cubital Doppler measurement | The diameter of the vessel in centimeters will be measured using a Duplex Doppler. | Up to 8 weeks after start of the intervention | 
| Radial Artery Doppler measurement | The diameter of the vessel in centimeters will be measured using a Duplex Doppler. | Up to 8 weeks after start of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Fistula, Access Failure, Hemodialysis Fistula Creation