Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

NCT ID: NCT03988270

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2021-11-09

Brief 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.

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.

Conditions

Arterio-venous Fistula; Kidney Failure; Hemodialysis Access Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Control

Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Rocco, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00058671

Identifier Type: -

Identifier Source: org_study_id