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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
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:
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:
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
Source of funding: Not available
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Isometric exercises | No Intervention | They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiocephalic fístula flow ( millimeters/minuts) | 8 weeks ultrasonography parameter of maturation |
| Measure | Description | Time Frame |
|---|---|---|
| Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention | 8 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucía Inés Martínez Carnovale, MD | Contact | +340615950992 | luciaimartinez@hotmail.com | |
| Lucía Inés Martínez Carnovale, MD | Contact | +34 615950992 | luciaimartinez@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lucía Inés Martínez Carnovale, MD | Hospital de Terrassa CST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucía Inés Martínez Carnovale | Recruiting | Terrassa | Barcelona | 08227 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9890327 | Background | 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. | |
| 12640286 | 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. |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| 26486682 | 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. |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |