Neuromuscular Electrostimulation in Radiocephalic Fistula (NMS)
Primary Purpose
Arteriovenous Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuromuscular electrostimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Arteriovenous Fistula
Eligibility 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
Sites / Locations
- Lucía Inés Martínez CarnovaleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Neuromuscular electrostimulation
Isometric exercises
Arm Description
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).
They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg).
Outcomes
Primary Outcome Measures
Radiocephalic fístula flow ( millimeters/minuts)
Secondary Outcome Measures
Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention
Full Information
NCT ID
NCT02925845
First Posted
September 29, 2016
Last Updated
October 4, 2016
Sponsor
Hospital de Terrassa
1. Study Identification
Unique Protocol Identification Number
NCT02925845
Brief Title
Neuromuscular Electrostimulation in Radiocephalic Fistula
Acronym
NMS
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Terrassa
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular electrostimulation
Arm Type
Experimental
Arm Description
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).
Arm Title
Isometric exercises
Arm Type
No Intervention
Arm Description
They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg).
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrostimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiocephalic fístula flow ( millimeters/minuts)
Time Frame
8 weeks ultrasonography parameter of maturation
Secondary Outcome Measure Information:
Title
Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucía Inés Martínez Carnovale, MD
Phone
+340615950992
Email
luciaimartinez@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lucía Inés Martínez Carnovale, MD
Phone
+34 615950992
Email
luciaimartinez@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucía Inés Martínez Carnovale, MD
Organizational Affiliation
Hospital de Terrassa CST
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucía Inés Martínez Carnovale
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucía Inés Martinez Carnovale, MD
Phone
+34 615950992
Email
luciaimartinez@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9890327
Citation
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.
Results Reference
background
PubMed Identifier
12640286
Citation
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.
Results Reference
background
PubMed Identifier
26486682
Citation
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.
Results Reference
background
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Neuromuscular Electrostimulation in Radiocephalic Fistula
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