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Completed

NCT Number: NCT04034433

Exercise Program for Arteriovenous Fistula Maturation

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).

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Key information

Conditions

Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Handgrip exercise program

Procedure

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 outcomes

  1. Arteriovenous Fistula (AVF diameter)

    Time frame: at 6 weeks (after surgery)

    Arteriovenous Fistula diameter will be measured by Doppler ultrasound

Secondary outcomes

  1. Echographic maturation rate

    Time frame: at 6 weeks (after surgery)

    Maturation rate of Arteriovenous Fistula (AVF) by echography defined as blood flow>600milliLiters/minute (mL/min), diameter>6millimeters (mm) and depth <6mm

  2. Clinical maturation rate

    Time frame: at 6 weeks (after surgery)

    Arteriovenous Fistula (AVF) measured by a vein easily palpable, relatively straight, with a uniform sensation of quivering and more than 10centimeters (cm) long.

  3. Arteriovenous Fistula (AVF) localization (arm or forearm)

    Time frame: at 6 weeks (after surgery)

    After the patient's examination, the vascular surgeon will choose the future AVF localization

  4. Arteriovenous Fistula (AVF) interventions

    Time frame: up to 6 weeks

    Necessity of performing an intervention (such as angioplasty or thrombolysis or thrombectomy or superficialization) on the Arteriovenous Fistula (AVF)

  5. Emergency hemodialysis on Central Venous Catheter (CVC)

    Time frame: up to 6 weeks

    Necessity of patients on CVC to undergo emergency hemodialysis

  6. Emergency hemodialysis on Arteriovenous Graft (AVG)

    Time frame: up to 6 weeks

    Necessity of patients on AVG to undergo emergency hemodialysis

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: FAVULOUS

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2019
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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