Skip to content

Neuromuscular Electrostimulation in Radiocephalic Fistula

Neuromuscular Electrostimulation Effect on the Maturation of Native Vascular Access (VA) Patients With Kidney Disease 5- Chronic Stages 5d Estimated by Doppler Ultrasound

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02925845
Acronym
NMS
Enrollment
34
Registered
2016-10-06
Start date
2015-01-31
Completion date
2017-01-31
Last updated
2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula

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

Detailed description

* 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 * At baseline, patients included in the study the main demographic variables were collected, anthropometric, biochemical parameters, hemodynamic data, Eco Doppler of AV (ECO mapping) and prescribed medical treatment. * Likewise, they will be made an assessment of their muscle strength by skinfold and upper limb static dynamometry in which was made the native AV. * During the study period the following phases were established: • Phase 1 (4 weeks): * The control group will receive the usual care on an outpatient AV. * Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program) after 7 days of completion of native AV. * At the end of this phase both groups were conducted an ECO doppler (ECO4s) AV regulated by Vascular Surgery. • Phase 2 (8 weeks): * The control group will receive the usual care on an outpatient AV. * Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program) * At the end of this phase, both groups were conducted an ECO doppler (ECO8s) is regulated by the AV Vascular Surgery * During all phases of the study, patients on hemodialysis follow their analytical controls programmed by Nephrology and receive medical treatment according to standard clinical practice. * At the end of each phase of the study, all patients were performed an assessment of their muscle strength by centimetría, skinfold thickness and static dynamometry member in which AV has been made. * Calendar: A provisional timetable is presented * Presentation of the CEIC study: September 2014 * inclusion Period: 78 weeks * Follow-up period: 2 months * Close database: 1 month * Statistical analysis: 1 month * Source of funding: Not available

Interventions

DEVICENeuromuscular electrostimulation

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.

Sponsors

Hospital de Terrassa
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Inclusion criteria: * 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 *

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Radiocephalic fístula flow ( millimeters/minuts)8 weeks ultrasonography parameter of maturation

Secondary

MeasureTime frame
Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention8 weeks

Countries

Spain

Contacts

Primary ContactLucía Inés Martínez Carnovale, MD
luciaimartinez@hotmail.com+340615950992
Backup ContactLucía Inés Martínez Carnovale, MD
luciaimartinez@hotmail.com+34 615950992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026