Neuromuscular Electrostimulation in Radiocephalic Fistula (NMS)

Hospital de Terrassa

Status: Unknown

Conditions: Arteriovenous Fistula

Treatments: Device: Neuromuscular electrostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02925845

VES-COMPAVI-2014-01

Details and patient eligibility

About

• 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

Full 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

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Neuromuscular electrostimulation

Experimental group

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).

Treatment:

Device: Neuromuscular electrostimulation

Isometric exercises

No Intervention group

Description:

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