Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988270
• Other study ID #: IRB00058671
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: November 9, 2021

Study information

• Verified date: June 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 9, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterio-venous Fistula
• Arteriovenous Fistula
• Fistula
• Hemodialysis Access Failure
• Kidney Failure
• Renal Insufficiency

Intervention

Other:
• Exercise
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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Mean Number of hand grips per day		Up to 8 weeks after start of the intervention
Secondary	Mean Number of days hand grips performed		Up to 8 weeks after start of the intervention
Secondary	Total mean number of hand grip repetitions performed		Up to 8 weeks after start of the intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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