HemodialysisNCT07787195
Low-Level Laser Therapy Versus Isometric Handgrip Exercise On Arteriovenous Fistula Maturation in Hemodialysis Patients
A study testing Low-level laser therapy, Isometric handgrip exercises and Standard postoperative care in people with Hemodialysis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the effectiveness of low-level laser therapy (LLLT) compared with isometric handgrip exercise and standard care in promoting vascular remodeling of arteriovenous fistulas (AVFs) among hemodialysis patients. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Low-level laser therapy, Isometric handgrip exercises and Standard postoperative care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders.
- Patient age between 35 and 50 years.
- Diagnosed with chronic kidney disease (CKD) Stage 4 or 5 with a newly created radiocephalic arteriovenous fistula (RC-AVF), including both pre-dialysis patients and those temporarily receiving hemodialysis via central venous catheter pending fistula maturation.
- Distal forearm cephalic vein diameter ≥ 2.5 mm in the non-dominant hand
Who cannot join
- History of prior vascular access surgery on the same limb.
- Physical or mental disability limiting the ability to perform exercises.
- Positive Allen's test.
- Absent or thrombosed distal forearm cephalic vein.
- Already undergoing regular exercise (including manual workers).
- History of hemophilia or known coagulation disorder.
Show all 9Show fewer
- Personal or family history of cancer.
- Severe cardiac disease (congestive heart failure with ejection fraction ≤ 20%).
- Known central venous stenosis > 50% on the side of planned arteriovenous fistula creation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo university
Cairo
Muhammed A Ibrahim, Bachlor, 01114499767, muhammd.3atef74@gmail.com
About this study
The purpose of this study is to evaluate the effectiveness of low-level laser therapy (LLLT) compared with isometric handgrip exercise and standard care in promoting vascular remodeling of arteriovenous fistulas (AVFs) among hemodialysis patients.
Read the detailed description
Hemodialysis remains a life-sustaining therapy for patients with end-stage renal disease, and the creation of a reliable arteriovenous fistula (AVF) is considered the gold standard for vascular access. However, despite its clinical advantages, AVF maturation failure occurs in up to 40% of patients, often due to inadequate vein dilation or early stenosis. Such shortcomings can delay dialysis initiation, increase the need for central venous catheters, and heighten the risk of infection and hospitalization. Interventions that can support or accelerate vascular remodeling and improve AVF usability, therefore, remain a significant focus in nephrology and vascular research.
Several strategies have been investigated to enhance AVF maturation, including surgical modifications, pharmacological therapies, and rehabilitative interventions. Among conservative methods, isometric handgrip exercise has shown promise by improving venous return, stimulating shear stress, and promoting dilation of the access vein. More recently, low-level laser therapy (LLLT) has gained attention for its ability to modulate endothelial function, stimulate nitric oxide release, and improve microcirculation, with preliminary evidence suggesting beneficial effects on vascular tone and tissue healing. Nevertheless, comparative data between exercise-based and photobiomodulation-based approaches remain limited.
This study is significant because it directly compares two non-invasive interventions-LLLT and isometric handgrip exercise-for their ability to enhance the vascular diameter of AVFs in hemodialysis patients. By clarifying whether photobiomodulation offers comparable or superior outcomes to exercise, the findings may help guide clinicians in selecting effective, patient-appropriate strategies to optimize AVF maturation and long-term patency. Ultimately, this research addresses a critical gap in vascular access management and may contribute to reducing access-related complications, improving dialysis efficiency, and enhancing the quality of life for patients dependent on chronic hemodialysis.
To our knowledge, this is the first randomized controlled trial to evaluate extravascular low-level laser therapy head-to-head with isometric handgrip exercise for promoting radiocephalic arteriovenous fistula maturation in patients with chronic kidney disease.
- Conditions
- Hemodialysis
- Being tested
- Low-level laser therapy, Isometric handgrip exercises, Standard postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyDevice
Patients in this group will receive low-level laser therapy using the BS-W11 semiconductor low-level laser device, which emitted a red laser at 650 nm with a power output of 5 mW per diode. The laser will be applied over the arteriovenous fistula site. Each session lasts 30 minutes and is administered three times a week for a total period of eight consecutive weeks. A trained therapist will perform all procedures, and patients were monitored for any potential adverse reactions during and after each session.
Isometric handgrip exercisesOther
Patients will be instructed to perform daily isometric handgrip exercises using a standard squeeze ball. Patients will be positioned seated comfortably, with the forearm of the exercising limb resting on the ipsilateral thigh and the elbow maintained in slight flexion throughout the exercise, in order to minimize compensatory shoulder and elbow movement and ensure that the contraction remained isolated to the forearm muscles. The exercise protocol involves squeezing at a rate of approximately 20 squeezes per minute for a total of 30 minutes per day, at 30-40% of maximum voluntary contraction (MVC). To improve compliance, participants will be allowed to divide the daily session into two 15-minute intervals if required. The exercise program continued for 8 consecutive weeks, and patients will be instructed to maintain adherence by recording their daily sessions in a logbook
Standard postoperative careOther
It includes wound and dressing management (keeping the dressing dry for the initial 48-72 hours, followed by regular dressing changes and site hygiene), activity restriction (avoiding heavy lifting or direct pressure over the access site during the early postoperative period), patient education on self-palpation of the access thrill, and routine follow-up visits at approximately 1 week and 6 weeks postoperatively to assess wound healing and access patency.
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy group | Experimental | Patients received extravascular low-level laser therapy (LLLT) in the form of a laser watch device applied just above the wrist joint, three sessions weekly for 8 weeks. Receives: Device: Low-level laser therapy |
| Isometric Handgrip Exercise group | Experimental | Patients performed isometric handgrip exercise using a calibrated handgrip dynamometer/squeeze ball daily for 8 weeks. Receives: Other: Isometric handgrip exercises |
| Standard postoperative care | Active comparator | Patients will receive standard postoperative care only, with no additional intervention. Receives: Other: Standard postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Vein Diameter
It will be measured by the doppler ultrasound. The internal luminal diameter of the arteriovenous fistula (cephalic vein), measured in millimeters (mm) by duplex ultrasound at a standardized point along the fistula tract, typically 5-10 cm proximal to the anastomosis, with the patient in a seated or semi-recumbent position and a tourniquet applied to standardize venous filling. A diameter ≥6 mm is generally considered indicative of adequate fistula maturation.
Measured: 8 weeks
Rate of blood flow
It will me measured by the doppler ultrasound. The volumetric rate of blood flow through the arteriovenous fistula, measured in milliliters per minute (mL/min) using duplex ultrasound Doppler assessment at a standardized site along the fistula outflow vein. Access flow is calculated from the vessel cross-sectional area and the time-averaged mean velocity (TAMV), as follows:
Access Flow (Qa) = π × (D / 2)2 × TAMV × 60 where D = vein diameter (cm), TAMV = time-averaged mean velocity (cm/s), and 60 converts cm³/s to mL/min.
A flow rate >600 mL/min is generally considered indicative of adequate fistula maturation.
Measured: 8 weeks
Time-Averaged Mean Velocity (TAMV)
The mean blood flow velocity within the fistula vein, averaged over the complete cardiac cycle, obtained by pulsed-wave Doppler ultrasound.. TAMV is expressed in centimeters per second (cm/s) and is used, together with the vessel cross-sectional area, to derive access flow.
Measured: 8 weeks
Maturation of arteriovenous fistulas
It will be evaluated by duplex ultrasound at 8 weeks post-creation by a vascular sonographer. A composite clinical outcome indicating that the arteriovenous fistula has developed sufficient diameter, blood flow, and depth to permit successful and sustained cannulation for hemodialysis. Maturation is assessed at a predefined postoperative time point by duplex ultrasound against standardized criteria - vein diameter ≥6 mm, access flow >600 mL/min, and depth from the skin surface ≤6 mm - in conjunction with documented successful two-needle cannulation for dialysis.
Measured: 8 weeks
Secondary outcomes (2)
Pain intensity level
Pain intensity will be measured by applying the visual analogue scale (VAS). The VAS is a 100-mm horizontal line, with one end defined as no pain (0 mm) and the other as worst imaginable pain (100 mm). Each participant will be asked to mark a point on the line corresponding to their level of pain at the arteriovenous fistula site. This procedure will be repeated three times, and the average will be recorded
Measured: 8 weeks
Kidney disease-related quality of life (KDQOL-36™)
The KDQOL-36™ will be used to assess health-related quality of life in patients with chronic kidney disease referred for hemodialysis vascular access. It is a validated, self-administered questionnaire that combines a generic core health survey with kidney-disease-targeted items, covering physical and mental health domains as well as burden of kidney disease, symptoms/problems, and effects of kidney disease on daily life. Higher scores reflect a better perceived quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Atef Ibrahim, Cairo University
- Investigators
- Mohamed F Radwan, Study director, Ain Shams UniversityHany E Obya, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787195
- Sponsor's protocol ID
- P.T.REC/012/006425
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Level Laser Therapy Versus Isometric Handgrip Exercise On Arteriovenous Fistula Maturation in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07787195
- Acronym / sponsor ID
- P.T.REC/012/006425
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Aug 2026 (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.
The purpose of this study is to evaluate the effectiveness of low-level laser therapy (LLLT) compared with isometric handgrip exercise and standard care in promoting vascular remodeling of arteriovenous fistulas (AVFs) among hemodialysis patients.
Detailed description
Hemodialysis remains a life-sustaining therapy for patients with end-stage renal disease, and the creation of a reliable arteriovenous fistula (AVF) is considered the gold standard for vascular access. However, despite its clinical advantages, AVF maturation failure occurs in up to 40% of patients, often due to inadequate vein dilation or early stenosis. Such shortcomings can delay dialysis initiation, increase the need for central venous catheters, and heighten the risk of infection and hospitalization. Interventions that can support or accelerate vascular remodeling and improve AVF usability, therefore, remain a significant focus in nephrology and vascular research.
Several strategies have been investigated to enhance AVF maturation, including surgical modifications, pharmacological therapies, and rehabilitative interventions. Among conservative methods, isometric handgrip exercise has shown promise by improving venous return, stimulating shear stress, and promoting dilation of the access vein. More recently, low-level laser therapy (LLLT) has gained attention for its ability to modulate endothelial function, stimulate nitric oxide release, and improve microcirculation, with preliminary evidence suggesting beneficial effects on vascular tone and tissue healing. Nevertheless, comparative data between exercise-based and photobiomodulation-based approaches remain limited.
This study is significant because it directly compares two non-invasive interventions-LLLT and isometric handgrip exercise-for their ability to enhance the vascular diameter of AVFs in hemodialysis patients. By clarifying whether photobiomodulation offers comparable or superior outcomes to exercise, the findings may help guide clinicians in selecting effective, patient-appropriate strategies to optimize AVF maturation and long-term patency. Ultimately, this research addresses a critical gap in vascular access management and may contribute to reducing access-related complications, improving dialysis efficiency, and enhancing the quality of life for patients dependent on chronic hemodialysis.
To our knowledge, this is the first randomized controlled trial to evaluate extravascular low-level laser therapy head-to-head with isometric handgrip exercise for promoting radiocephalic arteriovenous fistula maturation in patients with chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy group | Experimental | Device: Low-level laser therapyPatients received extravascular low-level laser therapy (LLLT) in the form of a laser watch device applied just above the wrist joint, three sessions weekly for 8 weeks. |
| Isometric Handgrip Exercise group | Experimental | Other: Isometric handgrip exercisesPatients performed isometric handgrip exercise using a calibrated handgrip dynamometer/squeeze ball daily for 8 weeks. |
| Standard postoperative care | Active comparator | Other: Standard postoperative carePatients will receive standard postoperative care only, with no additional intervention. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of both genders.
- Patient age between 35 and 50 years.
- Diagnosed with chronic kidney disease (CKD) Stage 4 or 5 with a newly created radiocephalic arteriovenous fistula (RC-AVF), including both pre-dialysis patients and those temporarily receiving hemodialysis via central venous catheter pending fistula maturation.
- Distal forearm cephalic vein diameter ≥ 2.5 mm in the non-dominant hand
Key exclusion criteria (9 listed)
- History of prior vascular access surgery on the same limb.
- Physical or mental disability limiting the ability to perform exercises.
- Positive Allen's test.
- Absent or thrombosed distal forearm cephalic vein.
- Already undergoing regular exercise (including manual workers).
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 |
|---|---|---|
| Low-level laser therapyPatients in this group will receive low-level laser therapy using the BS-W11 semiconductor low-level laser device, which emitted a red laser at 650 nm with a power output of 5 mW per diode. The laser will be applied over the arteriovenous fistula site. Each session lasts 30 minutes and is administered three times a week for a total period of eight consecutive weeks. A trained therapist will perform all procedures, and patients were monitored for any potential adverse reactions during and after each session. | Device | Low-level laser therapy group |
| Isometric handgrip exercisesPatients will be instructed to perform daily isometric handgrip exercises using a standard squeeze ball. Patients will be positioned seated comfortably, with the forearm of the exercising limb resting on the ipsilateral thigh and the elbow maintained in slight flexion throughout the exercise, in order to minimize compensatory shoulder and elbow movement and ensure that the contraction remained isolated to the forearm muscles. The exercise protocol involves squeezing at a rate of approximately 20 squeezes per minute for a total of 30 minutes per day, at 30-40% of maximum voluntary contraction (MVC). To improve compliance, participants will be allowed to divide the daily session into two 15-minute intervals if required. The exercise program continued for 8 consecutive weeks, and patients will be instructed to maintain adherence by recording their daily sessions in a logbook | Other | Isometric Handgrip Exercise group |
| Standard postoperative careIt includes wound and dressing management (keeping the dressing dry for the initial 48-72 hours, followed by regular dressing changes and site hygiene), activity restriction (avoiding heavy lifting or direct pressure over the access site during the early postoperative period), patient education on self-palpation of the access thrill, and routine follow-up visits at approximately 1 week and 6 weeks postoperatively to assess wound healing and access patency. | Other | Standard postoperative care |
Primary outcome
Average Vein Diameter
Time frame: 8 weeks
It will be measured by the doppler ultrasound. The internal luminal diameter of the arteriovenous fistula (cephalic vein), measured in millimeters (mm) by duplex ultrasound at a standardized point along the fistula tract, typically 5-10 cm proximal to the anastomosis, with the patient in a seated or semi-recumbent position and a tourniquet applied to standardize venous filling. A diameter ≥6 mm is generally considered indicative of adequate fistula maturation.
Rate of blood flow
Time frame: 8 weeks
It will me measured by the doppler ultrasound. The volumetric rate of blood flow through the arteriovenous fistula, measured in milliliters per minute (mL/min) using duplex ultrasound Doppler assessment at a standardized site along the fistula outflow vein. Access flow is calculated from the vessel cross-sectional area and the time-averaged mean velocity (TAMV), as follows: Access Flow (Qa) = π × (D / 2)2 × TAMV × 60 where D = vein diameter (cm), TAMV = time-averaged mean velocity (cm/s), and 60 converts cm³/s to mL/min. A flow rate >600 mL/min is generally considered indicative of adequate fistula maturation.
Time-Averaged Mean Velocity (TAMV)
Time frame: 8 weeks
The mean blood flow velocity within the fistula vein, averaged over the complete cardiac cycle, obtained by pulsed-wave Doppler ultrasound.. TAMV is expressed in centimeters per second (cm/s) and is used, together with the vessel cross-sectional area, to derive access flow.
Maturation of arteriovenous fistulas
Time frame: 8 weeks
It will be evaluated by duplex ultrasound at 8 weeks post-creation by a vascular sonographer. A composite clinical outcome indicating that the arteriovenous fistula has developed sufficient diameter, blood flow, and depth to permit successful and sustained cannulation for hemodialysis. Maturation is assessed at a predefined postoperative time point by duplex ultrasound against standardized criteria - vein diameter ≥6 mm, access flow >600 mL/min, and depth from the skin surface ≤6 mm - in conjunction with documented successful two-needle cannulation for dialysis.
2 secondary outcomes
Pain intensity level
Time frame: 8 weeks
Kidney disease-related quality of life (KDQOL-36™)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Hemodialysis
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
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.
Mohamed F Radwan study director
Ain Shams University
Hany E Obya, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy, Isometric handgrip exercises and Standard postoperative care in people with Hemodialysis, run by Cairo 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 9 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: opening soon, as of the sponsor's last update on 26 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed A Ibrahim, Bachelor (01114499767, Muhammd.3atef74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Vein Diameter (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 26 Aug 2026.