Exercise Program for Arteriovenous Fistula Maturation

Arteriovenous Fistula Clinical Trial

— FAVULOUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04034433
• Other study ID #: 69HCL19_0215
• Secondary ID: ID-RCB
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: November 4, 2026

Study information

• Verified date: September 2023
• Source: Hospices Civils de Lyon
• Contact: Abbas DEEB, PhD
• Phone: 04.72.67.87.03
• Email: abbas.deeb[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 4, 2026
• Est. primary completion date: November 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Procedure:
• Handgrip exercise program
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.

Locations

Country	Name	City	State
France	Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arteriovenous Fistula (AVF diameter)	Arteriovenous Fistula diameter will be measured by Doppler ultrasound	at 6 weeks (after surgery)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Emergency hemodialysis on Central Venous Catheter (CVC)	Necessity of patients on CVC to undergo emergency hemodialysis	up to 6 weeks
Secondary	Emergency hemodialysis on Arteriovenous Graft (AVG)	Necessity of patients on AVG to undergo emergency hemodialysis	up to 6 weeks