Exercise Program for Arteriovenous Fistula Maturation

Study Overview
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Brief Summary
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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).

Official Title
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Benefits of a Perioperative Exercise Program on Maturation of Dialysis Arteriovenous Fistulas

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Procedure: Handgrip exercise program


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Procedure: Handgrip exercise program<br>* Handgrip exercise with a rubber ball 4 weeks before the surgery until 4 weeks after the surgery 20 contractions per minute for a total of 20 minutes each day.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arteriovenous Fistula (AVF diameter) | Arteriovenous Fistula diameter will be measured by Doppler ultrasound | at 6 weeks (after surgery) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arteriovenous Fistula Diameter, Handgrip, Program exercise, Maturation