Neuromuscular Electrostimulation in Radiocephalic Fistula

NCT02925845 | Unknown

• 1 other identifier: VES-COMPAVI-2014-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

• Objective: To analyze the effect of neuromuscular electrostimulation in the maturation of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease (CKD) stage 5-5D
• Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting.
• Disease or disorder study: vascular Access maturation.
• Population: Patients with CKD stage 5-5D at the research center.
• Project duration: 78 weeks
• Methodology:
• Patients with CKD stages 5-5D that has undergone a native AV in service stations to give their informed consent and meeting the inclusion criteria will be included.
• At baseline two study groups were established:
• Group 1: neuromuscular electrostimulation
• Group 2: isometric exercises

Conditions

Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• Radiocephalic fístula flow ( millimeters/minuts)

  8 weeks ultrasonography parameter of maturation

Secondary Outcomes (1)

• Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention

  8 weeks

Study Arms (2)

Neuromuscular electrostimulation

EXPERIMENTAL

Patients assigned to the group NMS, following the visit Day Hospital, in the first two hours of each HD session will perform a program of neuromuscular electrostimulation of the limb with the RC-AVF performed in the reference position of the flexors and extensors forearm at the tip intervened in each HD session on the stage previously established in the protocol (duration according to established program).

Device: Neuromuscular electrostimulation

Isometric exercises

NO INTERVENTION

They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg).

Interventions

Neuromuscular electrostimulation DEVICE

The device CompexTheta 400i provided with various developmental programs rehabilitation exercise with different phases, types and current is used. an adaptive program (heating, toning, muscular atrophy, strength-endurance) will be established for each patient during the study period. It shall apply at the level of the muscle bellies of the flexor and extensor muscles of the forearm dela upper extremity AV created. Electrodes are positioned at the anatomical reference positions. The intensity of the current will increase until a tolerable muscle contraction and painless by the patient.

Neuromuscular electrostimulation

Eligibility Criteria

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

You may qualify if:

• Patients aged less than 18 years old
• Patients with tracking CCEE Nephrology than 3 months
• Patients with AV native AV upper limb without prior
• Patients give their written informed consent

You may not qualify if:

• prior cardiovascular event (acute myocardial infarction, unstable angina, stroke ....) in the last 3 months.
• AV prior to HD in same upper extremity
• Not have given informed written consent
• Carrier cardiac pacemaker

Sponsors & Collaborators

• Hospital de Terrassa: lead

Study Sites (1)

Lucía Inés Martínez Carnovale

Terrassa, Barcelona, 08227, Spain

RECRUITING

Related Publications (3)

• Brescia MJ, Cimino JE, Appell K, Hurwich BJ, Scribner BH. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. 1966. J Am Soc Nephrol. 1999 Jan;10(1):193-9. No abstract available.

  PMID: 9890327 BACKGROUND

• Leaf DA, MacRae HS, Grant E, Kraut J. Isometric exercise increases the size of forearm veins in patients with chronic renal failure. Am J Med Sci. 2003 Mar;325(3):115-9. doi: 10.1097/00000441-200303000-00003.

  PMID: 12640286 BACKGROUND

• Fontsere N, Mestres G, Yugueros X, Lopez T, Yuguero A, Bermudez P, Gomez F, Riambau V, Maduell F, Campistol JM. Effect of a postoperative exercise program on arteriovenous fistula maturation: A randomized controlled trial. Hemodial Int. 2016 Apr;20(2):306-14. doi: 10.1111/hdi.12376. Epub 2015 Oct 20.

  PMID: 26486682 BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucía Inés Martínez Carnovale, MD

  Hospital de Terrassa CST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucía Inés Martínez Carnovale, MD

CONTACT

+340615950992; luciaimartinez@hotmail.com

Lucía Inés Martínez Carnovale, MD

CONTACT

+34 615950992; luciaimartinez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 6, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)