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Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

Primary Purpose

Arterio-venous Fistula, Kidney Failure, Hemodialysis Access Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arterio-venous Fistula focused on measuring Hemodialysis, Fistula, Access Failure, Hemodialysis Fistula Creation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Mean Number of hand grips per day
Mean Number of days hand grips performed
Total mean number of hand grip repetitions performed
Cephalic Vein Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Basilic Vein Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Median Cubital Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Radial Artery Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

Full Information

First Posted
June 12, 2019
Last Updated
December 17, 2021
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03988270
Brief Title
Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterio-venous Fistula, Kidney Failure, Hemodialysis Access Failure
Keywords
Hemodialysis, Fistula, Access Failure, Hemodialysis Fistula Creation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with fistula usable without intervention
Description
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
Title
Number of participants with fistula usable with intervention
Description
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
Title
Number of participants with fistula not usable
Description
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
Secondary Outcome Measure Information:
Title
Mean Number of hand grips per day
Time Frame
Up to 8 weeks after start of the intervention
Title
Mean Number of days hand grips performed
Time Frame
Up to 8 weeks after start of the intervention
Title
Total mean number of hand grip repetitions performed
Time Frame
Up to 8 weeks after start of the intervention
Title
Cephalic Vein Doppler measurement
Description
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
Title
Basilic Vein Doppler measurement
Description
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
Title
Median Cubital Doppler measurement
Description
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
Title
Radial Artery Doppler measurement
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rocco, MD, MSCE
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

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