Low-Level Laser Therapy Versus Isometric Handgrip Exercise On Arteriovenous Fistula Maturation in Hemodialysis Patients

NCT07787195 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006425
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  8 weeks

Secondary Outcomes (2)

• Pain intensity level

  8 weeks

• Kidney disease-related quality of life (KDQOL-36™)

  8 weeks

Study Arms (3)

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.

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.

Other: Isometric handgrip exercises

Standard postoperative care

ACTIVE COMPARATOR

Patients will receive standard postoperative care only, with no additional intervention.

Other: Standard postoperative care

Interventions

Low-level laser therapy DEVICE

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.

Low-level laser therapy group

Isometric handgrip exercises OTHER

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

Isometric Handgrip Exercise group

Standard postoperative care OTHER

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.

Standard postoperative care

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mohamed F Radwan

  Ain Shams University

  STUDY DIRECTOR

• Hany E Obya, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Muhammed A Ibrahim, Bachelor

CONTACT

01114499767; Muhammd.3atef74@gmail.com

Hend A Abdel Monaem, PHD

CONTACT

01115507195; Drhendpt@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

EG (1)