Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial (PHYSICALFAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03213756
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
SEN (Spanish Society of Nephrology)
Information provided by (Responsible Party):
Ines Aragoncillo, Hospital General Universitario Gregorio Marañon

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
  • 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)

No Intervention: Control group
Control group patients will follow the usual surgical waiting list protocol (Estimated 1,5-2 months).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  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. [ 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.

  4. 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

  5. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: INES ARAGONCILLO, MD 0034639133043 ines.aragoncillo@iisgm.com

Locations
Layout table for location information
Spain
Hospital Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: INES ARAGONCILLO, MD    915868047    inesiglia@hotmail.com   
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
SEN (Spanish Society of Nephrology)
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Ines Aragoncillo, Nephrologist, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT03213756     History of Changes
Other Study ID Numbers: PHYSICALFAV
PHYSICALFAV ( Other Identifier: CEIC COMUNIDAD AUTÓNOMA MADRID (24.05.17) )
PHYSICALFAV ( Other Identifier: CEIC HOSPITAL GREGORIO MARAÑON (29.6.17) )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Primary and secondary outcome results will be included in the web site with in 12 month from the end of the study
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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
URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6275438/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ines Aragoncillo, Hospital General Universitario Gregorio Marañon:
doppler ultrasound
physical exercise
arteriovenous fistula maturation

Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Malformations
Thrombosis
Fistula
Arteriovenous Fistula
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Cardiovascular Abnormalities
Vascular Fistula
Congenital Abnormalities