Exercise Program for Arteriovenous Fistula Maturation (FAVULOUS)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Procedure: Handgrip exercise program

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abbas DEEB, PhD; Phone Number: 33 04.72.67.87.03; Email: abbas.deeb@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud
    • Contact: Laetitia KOPPE, MD; Phone Number: 04.72.67.87.03; Email: laetitia.koppe@chu-lyon.fr
    • Sub-Investigator: Solenne PELLETIER, MD
    • Sub-Investigator: Mathilde NOUVIER, MD
    • Sub-Investigator: Elodie CHALENÇON, MD
    • Sub-Investigator: Etienne NOVEL-CATIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Exercise	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Abbas DEEB, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): November 4, 2026

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Handgrip; Maturation; Arteriovenous Fistula Diameter; Program exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 69HCL19_0215; ID-RCB (Other Identifier: 2023-A01937-38)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No