NCT07238855

Brief Summary

Patients with chronic kidney failure who require hemodialysis depend on a surgically created connection between an artery and a vein in the arm, known as an arteriovenous fistula. This connection allows blood to flow at a high enough rate for effective hemodialysis treatment. However, many arteriovenous fistulas do not enlarge or strengthen adequately after surgery, a process known as maturation. When maturation fails, the fistula may not provide enough blood flow, leading to delays in hemodialysis, repeated procedures, or the need for temporary catheters. Improving the maturation of arteriovenous fistulas is therefore essential for patient safety, comfort, and the long-term success of hemodialysis. Isometric hand-grip exercises, such as repeatedly squeezing a hand-held dynamometer, may help increase blood flow to the arm and stimulate the blood vessels that are part of the fistula. These exercises require the muscles to contract without changing length, which can encourage enlargement of the vein and the development of new small blood vessels in the forearm. Previous research suggests that improving hand-grip strength may support better vein remodeling and improved blood flow, both of which are important for fistula maturation. This study is designed to evaluate whether performing a structured program of isometric hand-grip exercises using a dynamometer can enhance the maturation and long-term openness (patency) of arteriovenous fistulas in adults receiving hemodialysis. Participants are randomly assigned to one of two groups: a control group that receives routine postoperative care, and an exercise group that performs hand-grip exercises for six weeks. All participants undergo ultrasound imaging of the fistula before starting the study and again after six weeks. The ultrasound measurements include fistula size, vein diameter, blood flow, and blood flow velocity. The goal of this study is to determine whether a simple, low-cost exercise intervention can help arteriovenous fistulas mature more successfully and reduce the need for additional procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

Arteriovenous fistula maturationArteriovenous fistula patencyHemodialysis vascular accessChronic kidney diseaseEnd-stage renal diseaseHand-grip exerciseIsometric muscle exerciseDynamometer training

Outcome Measures

Primary Outcomes (1)

  • Change in arteriovenous fistula blood flow volume measured by Doppler ultrasound

    Blood flow volume through the arteriovenous fistula (milliliters per minute) will be measured using duplex Doppler ultrasound at the outflow vein. The primary metric is the change in blood flow volume from baseline (before starting the hand-grip exercise program or standard care) to six weeks. Change will be calculated as the value at six weeks minus the baseline value for each participant.

    Baseline and six weeks after starting the hand-grip exercise program or standard care

Secondary Outcomes (3)

  • Change in arteriovenous fistula vein diameter measured by Doppler ultrasound

    Baseline and six weeks after starting the hand-grip exercise program or standard care

  • Change in hand-grip muscle strength of the dominant hand

    Baseline and six weeks after starting the hand-grip exercise program or standard care

  • Clinical usability of the arteriovenous fistula for hemodialysis

    Assessed at six weeks after starting the hand-grip exercise program or standard care

Study Arms (2)

Control Group - Standard Postoperative Care

NO INTERVENTION

Participants in this arm receive the standard postoperative care provided after the creation of an arteriovenous fistula for hemodialysis. They do not perform any structured exercise program. Routine follow-up assessments, including Doppler ultrasound evaluation of fistula diameter, blood flow, and blood flow velocity, are conducted at baseline and after six weeks.

Hand-Grip Exercise Group - Isometric Training With Dynamometer

EXPERIMENTAL

Participants in this arm receive standard postoperative care plus a structured isometric hand-grip exercise program using a hand-held dynamometer. The intervention consists of adjusting the dynamometer grip to hand size, positioning the arm at a ninety-degree angle, and performing three maximal-effort squeezes repeated to calculate average grip strength. Exercises are performed regularly for six weeks. Doppler ultrasound measurements of fistula diameter, vein caliber, blood flow, and blood flow velocity are obtained at baseline and after six weeks to evaluate maturation and patency.

Behavioral: Isometric Hand-Grip Exercise Training Using a Hand Dynamometer

Interventions

Participants perform a structured isometric hand-grip exercise program using a hand-held dynamometer for six weeks after creation of an arteriovenous fistula for hemodialysis. The grip handle is adjusted to the size of the hand, the elbow is flexed to a ninety-degree angle, and the participant performs repeated maximal voluntary hand-grip contractions according to a standardized schedule. Training is added to usual postoperative care and is monitored during follow-up visits.

Hand-Grip Exercise Group - Isometric Training With Dynamometer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 75 years
  • End-stage renal disease requiring hemodialysis
  • Patients undergoing hemodialysis through a surgically created arteriovenous fistula
  • Ability to provide written informed consent

You may not qualify if:

  • Failure or refusal to provide written informed consent
  • Amputation of the arm or fingers
  • Significant osteoarthritis of the hand or wrist
  • Severe physical disability preventing exercise performance
  • Active infection or ongoing hospitalization
  • Known underlying malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Nephrology and Dialysis Unit - Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, ChronicArteriovenous FistulaRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel randomized controlled study comparing standard postoperative care versus a structured isometric hand-grip exercise program using a dynamometer in adult hemodialysis patients with a surgically created arteriovenous fistula.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Internal Medicine and Nephrology

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

February 15, 2023

Primary Completion

January 15, 2024

Study Completion

February 15, 2024

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations