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Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF

NCT ID: NCT01886430

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to verify the effects of low frequency functional electrical stimulation in heart failure patients hospitalized for treatment of the syndrome.

Detailed Description

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The aim of this study is to assess the effects of low frequency functional electrical stimulation on control autonomic and peripheral function in heart failure patients hospitalized for treatment of the syndrome. A randomized clinical trial with 30 advanced heart failure patients will be randomly assigned to functional electrical stimulation (Functional EE, n= 15) e 2) sensory electrical stimulation (Sensory EE, n=15). The functional electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with frequency of 10 Hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds, resting time (time off) of 20 seconds and intensity according to the discomfort threshold of the patient , checked every day until achieve a maximum of 70mA. The session will last 60 minuts. It will be held every weekday for a period of 10 days. The effects of interventions on functional capacity, autonomic control, peripheral function, peripheral muscle strength and quality of life will be analyzed at baseline and at the end of the protocol.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Functional Electrical Stimulation

Functional Electrical Stimulation for 10 days

Group Type EXPERIMENTAL

Functional electrical stimulation

Intervention Type OTHER

Functional electrical stimulation for 10 days

Control Electrical Stimulation

Control Electrical Stimulation for 10 days

Group Type PLACEBO_COMPARATOR

Placebo electrical stimulation

Intervention Type OTHER

Placebo electrical stimulation for 10 days

Interventions

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Functional electrical stimulation

Functional electrical stimulation for 10 days

Intervention Type OTHER

Placebo electrical stimulation

Placebo electrical stimulation for 10 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced heart failure,
* Class Functional IV, according to the criteria of New York Heart Association (NYHA),
* Aged over 18 years,
* Etiology hypertensive, ischemic, idiopathic or chagas disease,
* Left ventricular ejection fraction ≤ 30%.

Exclusion Criteria

* Patients with hypertension lung disease and oxygen-dependent,
* Neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs,
* Insulin-dependent diabetes mellitus (type I),
* Peripheral arterial occlusive disease,
* Peripheral neuropathy,
* Use of pacemaker or implantable cardiodefibrillator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Raphaela Vilar Ramalho Groehs

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto do Coração - HC/FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FES

Identifier Type: -

Identifier Source: org_study_id