Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Access Failure; Kidney Failure; Arterio-venous Fistula
• Intervention / Treatment: Other: Exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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
NO_INTERVENTION: Control; Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Michael Rocco, MD, MSCE, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2019
• Primary Completion (ACTUAL): September 15, 2021
• Study Completion (ACTUAL): November 9, 2021

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Fistula; Hemodialysis; Access Failure; Hemodialysis Fistula Creation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Renal Insufficiency; Arteriovenous Fistula
• Other Study ID Numbers: IRB00058671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No