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临床试验/NCT02925845
NCT02925845Unknown不适用

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

Hospital de Terrassa1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
34
试验地点
1
主要终点
Radiocephalic fístula flow ( millimeters/minuts)

研究概览

简要总结

  • 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

详细描述

  • 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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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).

干预措施: Neuromuscular electrostimulation (Device)

Isometric exercises

No Intervention

They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg).

结局指标

主要结局

Radiocephalic fístula flow ( millimeters/minuts)

时间窗: 8 weeks ultrasonography parameter of maturation

次要结局

  • Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention(8 weeks)

研究者

发起方
Hospital de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucia Martínez Carnovale

Medical Doctor

Hospital de Terrassa

研究点 (1)

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