About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Low-level laser therapy
DevicePatients 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 exercises
Other interventionPatients 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 care
Other interventionIt 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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
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.
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