Chronic Kidney FailureNCT07238855
Effect of Isometric Hand Grip Exercises Using a Dynamometer on AV Fistula Maturation and Patency in Hemodialysis Patients
A study testing Isometric Hand-Grip Exercise Training Using a Hand Dynamometer in people with Chronic Kidney Failure and End-Stage Renal Disease, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Failure, End-Stage Renal Disease, Arteriovenous Fistula
- What is being tested?
- Isometric Hand-Grip Exercise Training Using a Hand Dynamometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura Nephrology and Dialysis Unit - Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Effect of Isometric Hand Grip Exercises Using a Dynamometer on Arteriovenous Fistula Maturation and Patency in Hemodialysis Patients
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.
Read more
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.
- Being tested
- Isometric Hand-Grip Exercise Training Using a Hand Dynamometer
- Keywords
- Arteriovenous fistula maturation, Arteriovenous fistula patency, Hemodialysis vascular access, Chronic kidney disease, End-stage renal disease, Hand-grip exercise, Isometric muscle exercise, Dynamometer training
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Hand-Grip Exercise Training Using a Hand DynamometerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Isometric Hand-Grip Exercise Training Using a Hand Dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Vein diameter of the arteriovenous fistula (millimeters) will be measured using duplex Doppler ultrasound at the inflow and outflow segments. The metric is the change in vein diameter from baseline to six weeks.
Measured: Baseline and six weeks after starting the hand-grip exercise program or standard care
Change in hand-grip muscle strength of the dominant hand
Maximum isometric hand-grip strength (kilograms or newtons) will be assessed using a calibrated hand-held dynamometer. Each participant performs three maximal voluntary contractions with the dominant hand, and the mean of the three values is recorded. The metric is the change in hand-grip strength from baseline to six weeks.
Measured: Baseline and six weeks after starting the hand-grip exercise program or standard care
Clinical usability of the arteriovenous fistula for hemodialysis
Proportion of participants whose arteriovenous fistula can be used successfully for routine hemodialysis, defined as achieving two-needle cannulation with the prescribed blood flow rate during at least three consecutive hemodialysis sessions without access failure or thrombosis.
Measured: Assessed at six weeks after starting the hand-grip exercise program or standard care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start15 Feb 2023
- Primary completion15 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Zidan, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238855
- Sponsor's protocol ID
- MS.23.01.2266
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isometric Hand Grip Exercises Using a Dynamometer on Arteriovenous Fistula Maturation and Patency in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07238855
- Acronym / sponsor ID
- MS.23.01.2266
- Keywords
- Arteriovenous fistula maturation, Arteriovenous fistula patency, Hemodialysis vascular access, Chronic kidney disease, End-stage renal disease, Hand-grip exercise, Isometric muscle exercise, Dynamometer training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Isometric Hand-Grip Exercise Training Using a Hand DynamometerParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric Hand-Grip Exercise Training Using a Hand DynamometerParticipants 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. | Behavioural | Hand-Grip Exercise Group - Isometric Training With Dynamometer |
Primary outcome
Change in arteriovenous fistula blood flow volume measured by Doppler ultrasound
Time frame: Baseline and six weeks after starting the hand-grip exercise program or standard care
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.
3 secondary outcomes
Change in arteriovenous fistula vein diameter measured by Doppler ultrasound
Time frame: Baseline and six weeks after starting the hand-grip exercise program or standard care
Change in hand-grip muscle strength of the dominant hand
Time frame: Baseline and six weeks after starting the hand-grip exercise program or standard care
Clinical usability of the arteriovenous fistula for hemodialysis
Time frame: Assessed at six weeks after starting the hand-grip exercise program or standard care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Hand-Grip Exercise Training Using a Hand Dynamometer in people with Chronic Kidney Failure and End-Stage Renal Disease, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arteriovenous fistula blood flow volume measured by Doppler ultrasound (time frame: Baseline and six weeks after starting the hand-grip exercise program or standard care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.