FAVULOUS: Exercise Program for Arteriovenous Fistula Maturation

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04034433

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Arteriovenous Fistula	Procedure: Handgrip exercise program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 4, 2019

Anticipated Primary Completion Date :

Nov 4, 2022

Anticipated Study Completion Date :

Nov 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control

Arm

Intervention/Treatment

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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Arteriovenous Fistula (AVF diameter) [at 6 weeks (after surgery)]
Arteriovenous Fistula diameter will be measured by Doppler ultrasound

Secondary Outcome Measures

Echographic maturation rate [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
Clinical maturation rate [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.
Arteriovenous Fistula (AVF) localization (arm or forearm) [at 6 weeks (after surgery)]
After the patient's examination, the vascular surgeon will choose the future AVF localization
Arteriovenous Fistula (AVF) interventions [up to 6 weeks]
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) [up to 6 weeks]
Necessity of patients on CVC to undergo emergency hemodialysis
Emergency hemodialysis on Arteriovenous Graft (AVG) [up to 6 weeks]
Necessity of patients on AVG to undergo emergency hemodialysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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