Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial

Summary

A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. The distal forearm AVF is known as the best option but not all patients are good candidates for this surgery, and there is a primary failure rate between 20 and 50% published in literature.

The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis. These characteristics can be modified by performing physical exercise Some vascular access guidelines suggest the performance of isometric exercises in the pre and postoperative period of the AVF confection. However, there is very little data in literature on the possible efficacy of preoperative exercise, although small published observational studies point to an improvement in the venous and arterial caliber. Regarding the postoperative exercises, they do seem to improve maturation, however the degree of evidence in literature is low and there is no consensus on the exercise protocol to follow.

We present an open-label, multicenter, prospective, controlled and randomized study in order to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1, one group of patients will perform PIE for 8 weeks and the other group of patients will be a control group. The main purpose will be to evaluate if there is a lower rate of primary failure in the PIE group compared with control group.

Conditions

• Arteriovenous Fistula Thrombosis
• Arteriovenous Fistula Stenosis

Interventions

DEVICE

Isometric exercises using Hand grip and elastic bands

* Isometric exercises using hand-grip. This exercise consists of two sets of 30 hand-grip contractions with the hand of the upper arm candidate for AVF (in case of doubts about the most appropriate arm for AVF the exercise will be performed with both arms). The patient will rest one minute every 10 contractions and 5 minutes between both sets. The patient will repeat this protocol twice a day, morning and night (Approximately 15 minutes each session). The contraction intensity will start with half of the maximum force obtained by dynamometry and will be increased or decreased to be placed on an effort intensity 2-3 in the Borg scale. * Isometric exercise using elastic bands. At noon the patient will perform a slow contraction session using elastic band with 20 slow repetitions with the arm in flexion and 20 repetitions with the arm in extension. (Total duration: less than 10 minutes)

Sponsors & Collaborators

• Spanish Society of Nephrology

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  lead OTHER

Principal Investigators

• INES ARAGONCILLO, MD · GREGORIO MARAÑON HOSPITAL

• ALMUDENA VEGA, MD PHD · GREGORIO MARAÑON HOSPITAL

• SORAYA ABAD, MD · GREGORIO MARAÑON HOSPITAL

• NICOLAS MACIAS, MD · GREGORIO MARAÑON HOSPITAL

• JOSE MANUEL LIGERO, MD · GREGORIO MARAÑON HOSPITAL

• ROSARIO GARCIA PAJARES, MD · GREGORIO MARAÑON HOSPITAL

• ANGEL LUIS MORALES, MD · GREGORIO MARAÑON HOSPITAL

• TERESA CERVERA, MD · GREGORIO MARAÑON HOSPITAL

• JAVIER RIO, MD · GREGORIO MARAÑON HOSPITAL

• DIEGO RUIZ CHIRIBOGA, MD · GREGORIO MARAÑON HOSPITAL

• ELENA MENENDEZ, MD · GREGORIO MARAÑON HOSPITAL

• MARTA ALBALATE, MD PHD · HOSPITAL INFANTA LEONOR

• JARA AMPUERO, MD · HOSPITAL DEL SURESTE

• COVADONGA HEVIA, MD · Hospital Infanta Sofia

• SILVIA CALDES, MD · Hospital Infanta Sofia

• YESIKA AMEZQUITA, MD · Hospital Infanta Sofia

• YOLANDA HERNANDEZ, MD · Hospital Infanta Sofia

• CRISTINA MORATILLA, MD PHD · CLINICA FUENSANTA

• CARMEN CABRE, MD · CLINICA FUENSANTA

• JOSE LUIS MARTIN CONTY · CASTILLA LA MANCHA UNIVERSITY

• CRISTINA FERNANDEZ, MD PHD · Hospital Clinico de Madrid

• ISRAEL LEBLIC, MD · Hospital Universitario La Paz

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-18

Primary Completion

2019-07-31

Completion

2019-10-30

Countries

• Spain

Study Locations