Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial (PHYSICALFAV)
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|ClinicalTrials.gov Identifier: NCT03213756|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Fistula Thrombosis Arteriovenous Fistula Stenosis||Device: Isometric exercises using Hand grip and elastic bands||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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|
|Masking:||None (Open Label)|
|Official Title:||Effect of Isometric Preoperative Exercise on Vascular Caliber and the Maturation of Autologous Arteriovenous Fistulas. Randomized Clinical Trial|
|Actual Study Start Date :||July 18, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||October 30, 2019|
Experimental: Preoperative isometric exercise (PIE) group
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
No Intervention: Control group
Control group patients will follow the usual surgical waiting list protocol (Estimated 1,5-2 months).
- Impact of PIE on AVF primary failure comparing the control group and the PIE group. [ Time Frame: 12 weeks after AVF surgery (visit 6) ]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.
- Percentage of candidate patients for autologous distal or proximal AVF in both groups. [ Time Frame: 1 week after AVF surgery (visit 4) ]We will evaluate how many distal or proximal AVFs we perform in both groups. We expect an increase in the percentage of distal AVF in the PIE group
- Differences on the caliber of upper arm arteries and veins in the PIE group before and after isometric exercise. [ Time Frame: 8 weeks follow up visit before surgery (visit 3) ]Caliber, resistance index and flow of radial and brachial arteries and caliber of cephalic and basilic veins wil be measured in both groups using doppler ultrasound. We expect to find an increase in the diameters of arteries and veins in PIE group.
- 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. [ Time Frame: 12 weeks after AVF surgery (visit 6) ]This study will allow to protocolize the AVF maturation surveillance with Doppler ultrasound in all participating centers, with early detection of stenosis and optimization of the primary assisted patency of AVF in our patients.
- 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. [ Time Frame: 12 weeks after AVF surgery (visit 6) ]We will correlate the characteristics of arteria and vein and comorbidities of the patients with the AVFs outcomes in both groups in order to find the optimal characteristics of arteria and vein to perform an adequate AVF
- Impact of nutritional-inflammatory status on AVF outcomes [ Time Frame: 12 weeks after AVF surgery (visit 6) ]
We will study if there is any correlation between nutritional-inflammatory status of the patients included in both groups and the AVF outcomes.
The nutritional-inflammatory status will be evaluated with clinical and biochemical parameters, including endothelial disfunction biomarkers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213756
|Contact: INES ARAGONCILLO, MDfirstname.lastname@example.org|
|Hospital Gregorio Marañon||Recruiting|
|Madrid, Spain, 28007|
|Contact: INES ARAGONCILLO, MD 915868047 email@example.com|
|Principal Investigator:||INES ARAGONCILLO, MD||GREGORIO MARAÑON HOSPITAL|
|Study Chair:||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|