Arteriovenous FistulaFAVULOUSNCT04034433
Exercise Program for Arteriovenous Fistula Maturation
A study testing Handgrip exercise program in people with Arteriovenous Fistula, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Handgrip exercise program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2019to 26 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- no social welfare
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
Official title: 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).
- Conditions
- Arteriovenous Fistula
- Being tested
- Handgrip exercise program
- Keywords
- Arteriovenous Fistula Diameter, Handgrip, Program exercise, Maturation
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip exercise programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Procedure: Handgrip exercise program |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arteriovenous Fistula (AVF diameter)
Arteriovenous Fistula diameter will be measured by Doppler ultrasound
Measured: at 6 weeks (after surgery)
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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)
Measured: up to 6 weeks
Emergency hemodialysis on Central Venous Catheter (CVC)
Necessity of patients on CVC to undergo emergency hemodialysis
Measured: up to 6 weeks
Emergency hemodialysis on Arteriovenous Graft (AVG)
Necessity of patients on AVG to undergo emergency hemodialysis
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start4 Oct 2019
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbas DEEB, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034433
- Sponsor's protocol ID
- 69HCL19_0215
- Other IDs
- ID-RCB
- Acronym
- FAVULOUS
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Perioperative Exercise Program on Maturation of Dialysis Arteriovenous Fistulas
- ClinicalTrials.gov ID
- NCT04034433
- Acronym / sponsor ID
- FAVULOUS / 69HCL19_0215
- Conditions
- Arteriovenous Fistula
- Keywords
- Arteriovenous Fistula Diameter, Handgrip, Program exercise, Maturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Procedure: Handgrip exercise program |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- no social welfare
Key exclusion criteria (7 listed)
- contraindication for arteriovenous fistula (AVF) surgery
- refusing AVF creation
- prior vascular access
- antecedent of IV substance abuse
- active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handgrip exercise programHandgrip 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. | Procedure or surgery | Exercise |
Primary outcome
Arteriovenous Fistula (AVF diameter)
Time frame: at 6 weeks (after surgery)
Arteriovenous Fistula diameter will be measured by Doppler ultrasound
6 secondary outcomes
Echographic maturation rate
Time frame: at 6 weeks (after surgery)
Clinical maturation rate
Time frame: at 6 weeks (after surgery)
Arteriovenous Fistula (AVF) localization (arm or forearm)
Time frame: at 6 weeks (after surgery)
Arteriovenous Fistula (AVF) interventions
Time frame: up to 6 weeks
Emergency hemodialysis on Central Venous Catheter (CVC)
Time frame: up to 6 weeks
Emergency hemodialysis on Arteriovenous Graft (AVG)
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas DEEB, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip exercise program in people with Arteriovenous Fistula, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arteriovenous Fistula (AVF diameter) (time frame: at 6 weeks (after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.