Exercise Program for Arteriovenous Fistula Maturation

Not Applicable

Recruiting

• Conditions: Arteriovenous Fistula
• Interventions: Procedure: Handgrip exercise program

• Registration Number: NCT04034433
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Arteriovenous fistula (AVF) is the recommended vascular access for chronic hemodialysis, as it is associated with less mortality and better patency than arteriovenous graft (AVG) or central venous catheter (CVC).

Unfortunately, AVF suffers from a high failure rate, due, in part, to poor venous diameter.

The aim of this study is to investigate whether a perioperative handgrip training can improve the diameter of AVF in patients with chronic kidney disease (CKD) (stage IV-V).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2019-10-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-11-04
• Study Completion: 2026-11-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients older than 18 years
• with chronic kidney disease (Estimated Glomerular Filtration Rate (eGFR) <30 milliLiter/minute (mL/min))
• with follow-up at the University Hospital of Lyon Sud
• who choose hemodialysis as renal replacement therapy

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Exclusion Criteria

• contraindication for arteriovenous fistula (AVF) surgery
• refusing AVF creation
• prior vascular access
• antecedent of IV substance abuse
• active cancer
• inability to perform handgrip exercise
• physical or mental disability limiting follow-up possibility
• inclusion in an other interventional study
• no social welfare

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Handgrip exercise program	-

Primary Outcome Measures

Name	Time	Method
Arteriovenous Fistula (AVF diameter)	at 6 weeks (after surgery)	Arteriovenous Fistula diameter will be measured by Doppler ultrasound

Secondary Outcome Measures

Name	Time	Method
Emergency hemodialysis on Arteriovenous Graft (AVG)	up to 6 weeks	Necessity of patients on AVG to undergo emergency hemodialysis
Clinical maturation rate	at 6 weeks (after surgery)	Arteriovenous Fistula (AVF) measured by a vein easily palpable, relatively straight, with a uniform sensation of quivering and more than 10centimeters (cm) long.
Arteriovenous Fistula (AVF) interventions	up to 6 weeks	Necessity of performing an intervention (such as angioplasty or thrombolysis or thrombectomy or superficialization) on the Arteriovenous Fistula (AVF)
Echographic maturation rate	at 6 weeks (after surgery)	Maturation rate of Arteriovenous Fistula (AVF) by echography defined as blood flow\>600milliLiters/minute (mL/min), diameter\>6millimeters (mm) and depth \<6mm
Arteriovenous Fistula (AVF) localization (arm or forearm)	at 6 weeks (after surgery)	After the patient's examination, the vascular surgeon will choose the future AVF localization
Emergency hemodialysis on Central Venous Catheter (CVC)	up to 6 weeks	Necessity of patients on CVC to undergo emergency hemodialysis

Trial Locations

Locations (1)

Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France