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

December 2, 2015 updated by: Raphaela Vilar Ramalho Groehs, University of Sao Paulo General Hospital

Effects of Low-frequency Electrical Stimulation in Sympathetic Nerve Activity and Peripheral Vasoconstriction in Patients With Advanced HF

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Instituto do Coração - HC/FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Functional Electrical Stimulation
Functional Electrical Stimulation for 10 days
Other: Functional electrical stimulation
Functional electrical stimulation for 10 days
PLACEBO_COMPARATOR: Control Electrical Stimulation
Control Electrical Stimulation for 10 days
Other: Placebo electrical stimulation
Placebo electrical stimulation for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional assessment
Time Frame: 10 days
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral function
Time Frame: 10 days
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
10 days
Peripheral muscle strength
Time Frame: 10 days
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (ESTIMATE)

June 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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