NCT01450371

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

August 26, 2011

Last Update Submit

January 23, 2013

Conditions

Decreased Vascular Flow

Keywords

Autonomic Nervous SystemNeuromodulationBlood flow controlExercise

Outcome Measures

Primary Outcomes (1)

  • Muscle Metaboreflex Reflex

    Calf blood flow

    Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)

Study Arms (2)

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).

Device: Interferential

Placebo

The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current

Device: Interferential Placebo

Interventions

InterferentialDEVICE

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).

Also known as: Transcutaenous electrical stimuation
Interferential
Interferential PlaceboDEVICE

The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects without degenerative diseases.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Brasilia

Brasília, Federal District, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

Gaspar Rogério da Silva Chiappa

Porto Alegre, Rio Grande do Sul, 90820-001, Brazil

Location

Related Publications (1)

  • Vieira PJ, Ribeiro JP, Cipriano G Jr, Umpierre D, Cahalin LP, Moraes RS, Chiappa GR. Effect of transcutaneous electrical nerve stimulation on muscle metaboreflex in healthy young and older subjects. Eur J Appl Physiol. 2012 Apr;112(4):1327-34. doi: 10.1007/s00421-011-2084-z. Epub 2011 Jul 28.

    PMID: 21796410BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gaspar R Chiappa, Dr

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gaspar Rogério da Silva Chiappa

Study Record Dates

First Submitted

August 26, 2011

First Posted

October 12, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

BR(3)