NCT04034433

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

July 24, 2019

Last Update Submit

April 23, 2026

Conditions

Arteriovenous Fistula

Keywords

Arteriovenous Fistula DiameterHandgripProgram exerciseMaturation

Outcome Measures

Primary Outcomes (1)

  • Arteriovenous Fistula (AVF diameter)

    Arteriovenous Fistula diameter will be measured by Doppler ultrasound

    at 6 weeks (after surgery)

Secondary Outcomes (6)

  • Echographic maturation rate

    at 6 weeks (after surgery)

  • Clinical maturation rate

    at 6 weeks (after surgery)

  • Arteriovenous Fistula (AVF) localization (arm or forearm)

    at 6 weeks (after surgery)

  • Arteriovenous Fistula (AVF) interventions

    up to 6 weeks

  • Emergency hemodialysis on Central Venous Catheter (CVC)

    up to 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL
Procedure: Handgrip exercise program

Control

NO INTERVENTION

Interventions

Handgrip exercise programPROCEDURE

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.

Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • no social welfare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Abbas DEEB, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 26, 2019

Study Start

October 4, 2019

Primary Completion

January 26, 2026

Study Completion

January 26, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

FR(1)