Exercise Program for Arteriovenous Fistula Maturation

NCT ID: NCT04034433

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-04

Study Completion Date

2026-11-04

Brief Summary

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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).

Detailed Description

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Conditions

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Arteriovenous Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

Group Type EXPERIMENTAL

Handgrip exercise program

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abbas DEEB, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Abbas DEEB, PhD

Role: CONTACT

04.72.67.87.03 ext. 33

Facility Contacts

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Laetitia KOPPE, MD

Role: primary

04.72.67.87.03

Solenne PELLETIER, MD

Role: backup

Mathilde NOUVIER, MD

Role: backup

Elodie CHALENÇON, MD

Role: backup

Etienne NOVEL-CATIN, MD

Role: backup

Other Identifiers

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ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0215

Identifier Type: -

Identifier Source: org_study_id

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