Interferential Electrical Stimulation and Vasodilatation in Healthy Individuals (InterM)

January 23, 2013 updated by: GASPAR ROGERIO DA SILVA CHIAPPA, Principal Investigator, Hospital de Clinicas de Porto Alegre

Interferential Electrical Stimulation Improves Peripheral Vasodilatation in Healthy Individuals: A Randomized Crossover Study

Interferential electrical stimulation (IES) increases local blood flow. It is not known whether increases in blood flow may be caused by inhibition of sympathetic activity, mediated by muscle metaboreflex activity. The purpose of this study was to evaluate the effect of IES on metaboreflex activation in healthy subjects.

Study Overview

Status

Completed

Detailed Description

The study sample consisted of 11 healthy young individuals. All subjects were non-smokers, non-obese and free of any signs or symptoms of disease, as revealed by medical history, physical examination and electrocardiogram at rest and during cardiopulmonary exercise testing. Exclusion criteria were pregnancy, breast-feeding, alcohol or drug abuse, and any medication with potential effects on cardiovascular variables. Subjects were asked not to drink caffeine-containing drinks or exercise for at least 12 and 48 hours, respectively, before the experimental protocols.

Study Type

Observational

Enrollment (Actual)

11

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

    • DF
      • Brasilia, DF, Brazil
        • University of Brasilia
    • RS
      • Porto Alegre, RS, Brazil, 90035-007
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, RS, Brazil, 90820-001
        • Gaspar Rogério da Silva Chiappa

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects without degenerative diseases.

Description

Inclusion Criteria:

  • Subjects are non-smokers
  • non-obese
  • and free of any signs or symptoms of disease

Exclusion Criteria:

  • Pregnancy
  • breast-feeding
  • alcohol or drug abuse
  • medication with potential effects on cardiovascular variables

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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interferential
The individuals are treated acutely with interferential electrical stimulation (IES) during 30 min, providing a continuous flow of symmetrical rectangular interferential current biphasic pulses using bipolar electrodes with two channels and a slope of 1/5/1. The fixed current is adjusted to 4000 Hz, with the current AMF at 100 Hz and an AMF variation of 25 Hz (25% of AMF).
The individuals are treated acutely with IES during 30 min, providing a continuous flow of symmetrical rectangular interferential current biphasic pulses using bipolar electrodes with two channels and a slope of 1/5/1. The fixed current is adjusted to 4000 Hz, with the current AMF at 100 Hz and an AMF variation of 25 Hz (25% of AMF).
Other Names:
  • Transcutaenous electrical stimuation
Placebo
The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current
The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Metaboreflex Reflex
Time Frame: Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)
Calf blood flow
Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Gaspar R Chiappa, Dr, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

July 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

October 10, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 11-0374

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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