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Neuromuscular Electrostimulation in Radiocephalic Fistula (NMS)

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ClinicalTrials.gov Identifier: NCT02925845
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Lucia Martínez Carnovale, Hospital de Terrassa

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

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Device: Neuromuscular electrostimulation Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Neuromuscular Electrostimulation Effect on the Maturation of Native Vascular Access (VA) Patients With Kidney Disease 5- Chronic Stages 5d Estimated by Doppler Ultrasound
Study Start Date : January 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Neuromuscular electrostimulation
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
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.

No Intervention: Isometric exercises
They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg).



Primary Outcome Measures :
  1. Radiocephalic fístula flow ( millimeters/minuts) [ Time Frame: 8 weeks ultrasonography parameter of maturation ]

Secondary Outcome Measures :
  1. Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02925845


Contacts
Contact: Lucía Inés Martínez Carnovale, MD +340615950992 luciaimartinez@hotmail.com
Contact: Lucía Inés Martínez Carnovale, MD +34 615950992 luciaimartinez@hotmail.com

Locations
Spain
Lucía Inés Martínez Carnovale Recruiting
Terrassa, Barcelona, Spain, 08227
Contact: Lucía Inés Martinez Carnovale, MD    +34 615950992    luciaimartinez@hotmail.com   
Sponsors and Collaborators
Hospital de Terrassa
Investigators
Principal Investigator: Lucía Inés Martínez Carnovale, MD Hospital de Terrassa CST

Publications:
Responsible Party: Lucia Martínez Carnovale, Medical Doctor, Hospital de Terrassa
ClinicalTrials.gov Identifier: NCT02925845     History of Changes
Other Study ID Numbers: VES-COMPAVI-2014-01
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities