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Exercise Program for Arteriovenous Fistula Maturation (FAVULOUS)

Primary Purpose

Arteriovenous Fistula

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Handgrip exercise program
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arteriovenous Fistula focused on measuring Arteriovenous Fistula Diameter, Handgrip, Program exercise, Maturation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon SudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Outcomes

Primary Outcome Measures

Arteriovenous Fistula (AVF diameter)
Arteriovenous Fistula diameter will be measured by Doppler ultrasound

Secondary Outcome Measures

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
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.
Arteriovenous Fistula (AVF) localization (arm or forearm)
After the patient's examination, the vascular surgeon will choose the future AVF localization
Arteriovenous Fistula (AVF) interventions
Necessity of performing an intervention (such as angioplasty or thrombolysis or thrombectomy or superficialization) on the Arteriovenous Fistula (AVF)
Emergency hemodialysis on Central Venous Catheter (CVC)
Necessity of patients on CVC to undergo emergency hemodialysis
Emergency hemodialysis on Arteriovenous Graft (AVG)
Necessity of patients on AVG to undergo emergency hemodialysis

Full Information

First Posted
July 24, 2019
Last Updated
September 20, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04034433
Brief Title
Exercise Program for Arteriovenous Fistula Maturation
Acronym
FAVULOUS
Official Title
Benefits of a Perioperative Exercise Program on Maturation of Dialysis Arteriovenous Fistulas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
November 4, 2026 (Anticipated)
Study Completion Date
November 4, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
Keywords
Arteriovenous Fistula Diameter, Handgrip, Program exercise, Maturation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Handgrip exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arteriovenous Fistula (AVF diameter)
Description
Arteriovenous Fistula diameter will be measured by Doppler ultrasound
Time Frame
at 6 weeks (after surgery)
Secondary Outcome Measure Information:
Title
Echographic maturation rate
Description
Maturation rate of Arteriovenous Fistula (AVF) by echography defined as blood flow>600milliLiters/minute (mL/min), diameter>6millimeters (mm) and depth <6mm
Time Frame
at 6 weeks (after surgery)
Title
Clinical maturation rate
Description
Arteriovenous Fistula (AVF) measured by a vein easily palpable, relatively straight, with a uniform sensation of quivering and more than 10centimeters (cm) long.
Time Frame
at 6 weeks (after surgery)
Title
Arteriovenous Fistula (AVF) localization (arm or forearm)
Description
After the patient's examination, the vascular surgeon will choose the future AVF localization
Time Frame
at 6 weeks (after surgery)
Title
Arteriovenous Fistula (AVF) interventions
Description
Necessity of performing an intervention (such as angioplasty or thrombolysis or thrombectomy or superficialization) on the Arteriovenous Fistula (AVF)
Time Frame
up to 6 weeks
Title
Emergency hemodialysis on Central Venous Catheter (CVC)
Description
Necessity of patients on CVC to undergo emergency hemodialysis
Time Frame
up to 6 weeks
Title
Emergency hemodialysis on Arteriovenous Graft (AVG)
Description
Necessity of patients on AVG to undergo emergency hemodialysis
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abbas DEEB, PhD
Phone
04.72.67.87.03
Ext
33
Email
abbas.deeb@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbas DEEB, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia KOPPE, MD
Phone
04.72.67.87.03
Email
laetitia.koppe@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Solenne PELLETIER, MD
First Name & Middle Initial & Last Name & Degree
Mathilde NOUVIER, MD
First Name & Middle Initial & Last Name & Degree
Elodie CHALENÇON, MD
First Name & Middle Initial & Last Name & Degree
Etienne NOVEL-CATIN, MD

12. IPD Sharing Statement

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Exercise Program for Arteriovenous Fistula Maturation

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