Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial

NCT03213756 | Completed DMC

• 1 other identifier: PHYSICALFAV
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

doppler ultrasound; physical exercise; arteriovenous fistula maturation

Outcome Measures

Primary Outcomes (1)

• Impact of PIE on AVF primary failure comparing the control group and the PIE group.

  We will evaluate in both groups the primary failure rate. It will be evaluated during visit 6 (12 weeks after AVF creation). We expect a lower primary failure rate in the PIE group.

  12 weeks after AVF surgery (visit 6)

Secondary Outcomes (5)

• Percentage of candidate patients for autologous distal or proximal AVF in both groups.

  1 week after AVF surgery (visit 4)

• Differences on the caliber of upper arm arteries and veins in the PIE group before and after isometric exercise.

  8 weeks follow up visit before surgery (visit 3)

• Impact of AVF evaluation with doppler ultrasound in the postoperative period in both groups, adding the usual isometric exercise with ball contraction in all patients.

  12 weeks after AVF surgery (visit 6)

• Analysis of the optimal arterial and venous calibres to minimize the primary failure of AVF according to the individual risk factors in both groups of patients.

  12 weeks after AVF surgery (visit 6)

• Impact of nutritional-inflammatory status on AVF outcomes

  12 weeks after AVF surgery (visit 6)

Study Arms (2)

Preoperative isometric exercise (PIE) group

EXPERIMENTAL

In the PIE group, the patients will perform daily preoperative exercise protocol based on isometric exercises using hand grip and elastic bands. They will perform this protocol for at least six and ideally eight weeks before surgery.

Device: Isometric exercises using Hand grip and elastic bands

Control group

NO INTERVENTION

Control group patients will follow the usual surgical waiting list protocol (Estimated 1,5-2 months).

Interventions

Isometric exercises using Hand grip and elastic bands DEVICE

* 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)

Preoperative isometric exercise (PIE) group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signature.
• Age between 18 and 89 years.
• Patients with advanced chronic kidney disease, stages IV-V, in pre-dialysis or prevalent HD patients, requiring new AVF.

You may not qualify if:

• Absence of adequate arteries and veins to allow autologous AVF. (The minimum gauges that will be considered in order to perform an autologous AVF are: artery caliber equal or greater than 1.6 mm and vein caliber equal or greater than 1,8 mm with a compressor).
• Diagnosis of coagulopathy or hemoglobinopathy of any cause.
• Patients who urgently need an AVF without the possibility of being 8 weeks on the surgical waiting list.
• Impossibility to perform the physical exercise protocol due to physical or mental disabilities or lack of social support.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• Spanish Society of Nephrology: collaborator

Study Sites (1)

Hospital Gregorio Marañon

Madrid, 28007, Spain

Location

Related Publications (1)

• Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.

  PMID: 36184076 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• INES ARAGONCILLO, MD

  GREGORIO MARAÑON HOSPITAL

  PRINCIPAL INVESTIGATOR

• ALMUDENA VEGA, MD PHD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• SORAYA ABAD, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• NICOLAS MACIAS, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• JOSE MANUEL LIGERO, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• ROSARIO GARCIA PAJARES, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• ANGEL LUIS MORALES, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• TERESA CERVERA, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• JAVIER RIO, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• DIEGO RUIZ CHIRIBOGA, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• ELENA MENENDEZ, MD

  GREGORIO MARAÑON HOSPITAL

  STUDY CHAIR

• MARTA ALBALATE, MD PHD

  HOSPITAL INFANTA LEONOR

  STUDY CHAIR

• JARA AMPUERO, MD

  HOSPITAL DEL SURESTE

  STUDY CHAIR

• COVADONGA HEVIA, MD

  Hospital Infanta Sofia

  STUDY CHAIR

• SILVIA CALDES, MD

  Hospital Infanta Sofia

  STUDY CHAIR

• YESIKA AMEZQUITA, MD

  Hospital Infanta Sofia

  STUDY CHAIR

• YOLANDA HERNANDEZ, MD

  Hospital Infanta Sofia

  STUDY CHAIR

• CRISTINA MORATILLA, MD PHD

  CLINICA FUENSANTA

  STUDY CHAIR

• CARMEN CABRE, MD

  CLINICA FUENSANTA

  STUDY CHAIR

• JOSE LUIS MARTIN CONTY

  CASTILLA LA MANCHA UNIVERSITY

  STUDY CHAIR

• CRISTINA FERNANDEZ, MD PHD

  Hospital Clinico de Madrid

  STUDY CHAIR

• ISRAEL LEBLIC, MD

  Hospital Universitario La Paz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Model Details: Open-label, prospective, controlled, randomized, multicenter study in parallel groups, where in the preoperative AVF period, one group of patients will perform an isometric exercise protocol for 8 weeks and will be compared with a control group of patients that will not perform this preoperative exercise

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 11, 2017
• Study Start: July 18, 2017
• Primary Completion: July 31, 2019
• Study Completion: October 30, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Primary and secondary outcome results will be included in the web site with in 12 month from the end of the study
• Access Criteria: Public access

Locations

ES (1)