NCT03213756: PHYSICALFAV

Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial

Completed NA Last updated 6 March 2020

What this trial tests

NA trial testing Isometric exercises using Hand grip and elastic bands in Arteriovenous Fistula Thrombosis in 138 participants. Completed in 30 October 2019.

Timeline

18 July 2017

Primary endpoint
31 July 2019

30 October 2019

Quick facts

Lead sponsor	Hospital General Universitario Gregorio Marañon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	138
Start date	18 July 2017
Primary completion	31 July 2019
Estimated completion	30 October 2019
Sites	1 location across Spain

Drugs / interventions tested

• Isometric exercises using Hand grip and elastic bands

Conditions studied

• Arteriovenous Fistula Thrombosis — all drugs for Arteriovenous Fistula Thrombosis →
• Arteriovenous Fistula Stenosis — all drugs for Arteriovenous Fistula Stenosis →

Sponsor

Hospital General Universitario Gregorio Marañon

Who can join

Adults 18 to 95, any sex, with Arteriovenous Fistula Thrombosis or Arteriovenous Fistula Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sarcopenia in CKD: a roadmap from basic pathogenetic mechanisms to clinical trials.
   Ortiz A, Sanchez-Niño MD. · · 2019 · cited 25× · PMID 30746137 · DOI 10.1093/ckj/sfz001
2. Cellular and molecular mechanisms underlying hemodialysis arteriovenous fistula dysfunction and approaches to promote maturation: a vascular perspective.
   Shiu YT, Northrup H, Huang Y, Cho ME, et al · · 2025 · cited 7× · PMID 40465509 · DOI 10.1152/ajpheart.00010.2025
3. Effect of preoperative exercise on vascular caliber and maturation of arteriovenous fistula: the physicalfav trial, a randomized controlled study.
   Aragoncillo Sauco I, Hevia C, Manzano Grossi S, Amezquita Y, et al · · 2021 · cited 7× · PMID 33387342 · DOI 10.1007/s40620-020-00907-w
4. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access.
   Nantakool S, Reanpang T, Prasannarong M, Pongtam S, et al · · 2022 · cited 6× · PMID 36184076 · DOI 10.1002/14651858.cd013327.pub2
5. Rationale and design of the PHYSICALFAV trial: a randomized controlled trial to evaluate the effect of preoperative isometric exercise on vascular calibre and maturation of autologous arteriovenous fistulas.
   Aragoncillo I, Ligero JM, Hevia C, Morales AL, et al · · 2018 · cited 6× · PMID 30524719 · DOI 10.1093/ckj/sfy046