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Completed

NCT Number: NCT03988270

Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

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.

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Key information

Conditions

Arterio-venous Fistula Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Hemodialysis Access Failure Kidney Diseases Kidney Failure Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

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

Primary outcomes

  1. Number of participants with fistula usable without intervention

    Time frame: Up to 12 weeks after surgical creation of the AV fistula

    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.

  2. Number of participants with fistula usable with intervention

    Time frame: Up to 12 weeks after surgical creation of the AV fistula

    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.

  3. Number of participants with fistula not usable

    Time frame: Up to 12 weeks after surgical creation of the AV fistula

    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 outcomes

  1. Mean Number of hand grips per day

    Time frame: Up to 8 weeks after start of the intervention

  2. Mean Number of days hand grips performed

    Time frame: Up to 8 weeks after start of the intervention

  3. Total mean number of hand grip repetitions performed

    Time frame: Up to 8 weeks after start of the intervention

  4. Cephalic Vein Doppler measurement

    Time frame: Up to 8 weeks after start of the intervention

    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

  5. Basilic Vein Doppler measurement

    Time frame: Up to 8 weeks after start of the intervention

    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

  6. Median Cubital Doppler measurement

    Time frame: Up to 8 weeks after start of the intervention

    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

  7. Radial Artery Doppler measurement

    Time frame: Up to 8 weeks after start of the intervention

    The diameter of the vessel in centimeters will be measured using a Duplex Doppler.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2019
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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