NMS: Neuromuscular Electrostimulation in Radiocephalic Fistula
Study Details
Study Description
Brief Summary
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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
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Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting.
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Disease or disorder study: vascular Access maturation.
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Population: Patients with CKD stage 5-5D at the research center.
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Project duration: 78 weeks
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Methodology:
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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.
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At baseline two study groups were established:
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Group 1: neuromuscular electrostimulation
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Group 2: isometric exercises
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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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
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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
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Group 2: isometric exercises
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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.
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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.
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During the study period the following phases were established:
• Phase 1 (4 weeks):
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The control group will receive the usual care on an outpatient AV.
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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.
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At the end of this phase both groups were conducted an ECO doppler (ECO4s) AV regulated by Vascular Surgery.
• Phase 2 (8 weeks):
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The control group will receive the usual care on an outpatient AV.
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Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program)
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At the end of this phase, both groups were conducted an ECO doppler (ECO8s) is regulated by the AV Vascular Surgery
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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.
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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.
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Calendar: A provisional timetable is presented
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Presentation of the CEIC study: September 2014
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inclusion Period: 78 weeks
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Follow-up period: 2 months
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Close database: 1 month
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Statistical analysis: 1 month
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Source of funding: Not available
Study Design
Arms and Interventions
| 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.
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| No Intervention: Isometric exercises They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg). |
Outcome Measures
Primary Outcome Measures
- Radiocephalic fístula flow ( millimeters/minuts) [8 weeks ultrasonography parameter of maturation]
Secondary Outcome Measures
- Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention [8 weeks]
Eligibility Criteria
Criteria
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Inclusion criteria:
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Patients aged less than 18 years old
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Patients with tracking CCEE Nephrology than 3 months
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Patients with AV native AV upper limb without prior
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Patients give their written informed consent
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Exclusion criteria:
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prior cardiovascular event (acute myocardial infarction, unstable angina, stroke ....) in the last 3 months.
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AV prior to HD in same upper extremity
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Not have given informed written consent
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Carrier cardiac pacemaker
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lucía Inés Martínez Carnovale | Terrassa | Barcelona | Spain | 08227 |
Sponsors and Collaborators
- Hospital de Terrassa
Investigators
- Principal Investigator: Lucía Inés Martínez Carnovale, MD, Hospital de Terrassa CST
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Fontseré N, Mestres G, Yugueros X, López 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.
- 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.
- VES-COMPAVI-2014-01