An interventional study of Exercise in Arterio-venous Fistula, Kidney Failure and Hemodialysis Access Failure, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-10.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
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.
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 30 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
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Exclusion Criteria:
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
Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 weeks after surgical creation of the AV fistula
Mean Number of hand grips per day
Time frame: Up to 8 weeks after start of the intervention
Mean Number of days hand grips performed
Time frame: Up to 8 weeks after start of the intervention
Total mean number of hand grip repetitions performed
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 8 weeks after start of the intervention
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Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences