Low-Level Laser Therapy Versus Isometric Handgrip Exercise On Arteriovenous Fistula Maturation in Hemodialysis Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Muhammed A Ibrahim, Bachelor
- Numéro de téléphone: 01114499767
- E-mail: Muhammd.3atef74@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Hend A Abdel Monaem, PHD
- Numéro de téléphone: 01115507195
- E-mail: Drhendpt@cu.edu.eg
Lieux d'étude
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Cairo, Egypte
- Cairo University
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Contact:
- Muhammed A Ibrahim, Bachlor
- Numéro de téléphone: 01114499767
- E-mail: muhammd.3atef74@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Low-level laser therapy group
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.
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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.
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Expérimental: Isometric Handgrip Exercise group
Patients performed isometric handgrip exercise using a calibrated handgrip dynamometer/squeeze ball daily for 8 weeks.
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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
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Comparateur actif: Standard postoperative care
Patients will receive standard postoperative care only, with no additional intervention.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Average Vein Diameter
Délai: 8 weeks
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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.
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8 weeks
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Rate of blood flow
Délai: 8 weeks
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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
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Time-Averaged Mean Velocity (TAMV)
Délai: 8 weeks
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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.
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8 weeks
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Maturation of arteriovenous fistulas
Délai: 8 weeks
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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.
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8 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Pain intensity level
Délai: 8 weeks
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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
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8 weeks
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Kidney disease-related quality of life (KDQOL-36™)
Délai: 8 weeks
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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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8 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Mohamed F Radwan, Ain Shams University
- Chaise d'étude: Hany E Obya, Professor, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P.T.REC/012/006425
Informations sur les médicaments et les dispositifs, documents d'étude
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