Interferential Electrical Stimulation and Vasodilatation in Healthy Individuals (InterM)

This study has been completed.

Sponsor:

Collaborator:

University of Brasilia

Information provided by (Responsible Party):

GASPAR ROGERIO DA SILVA CHIAPPA, Principal Investigator, Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT01450371

First received: August 26, 2011

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Decreased Vascular Flow	Device: Interferential Device: Interferential Placebo

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Interferential Electrical Stimulation Improves Peripheral Vasodilatation in Healthy Individuals: A Randomized Crossover Study

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Muscle Metaboreflex Reflex [ Time Frame: Participants will be followed for the duration of metaboreflex activity (up to 30 minutes) ] [ Designated as safety issue: Yes ]
Calf blood flow

Enrollment:	11
Study Start Date:	July 2011
Study Completion Date:	October 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 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 Name: Transcutaenous electrical stimuation
Placebo The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current	Device: Interferential Placebo The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current

Groups/Cohorts

Assigned Interventions

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

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 Name: Transcutaenous electrical stimuation

Placebo

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

Device: Interferential Placebo

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy subjects without degenerative diseases.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450371

Locations

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

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

University of Brasilia

Investigators

Principal Investigator:

Gaspar R Chiappa, Dr

Hospital de Clinicas de Porto Alegre

More Information

No publications provided

Responsible Party:	GASPAR ROGERIO DA SILVA CHIAPPA, Principal Investigator, Gaspar Rogério da Silva Chiappa, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT01450371 History of Changes
Other Study ID Numbers:	11-0374
Study First Received:	August 26, 2011
Last Updated:	January 23, 2013
Health Authority:	Brazil: Ethics Committee

Keywords provided by Hospital de Clinicas de Porto Alegre:

Autonomic Nervous System
Neuromodulation
Blood flow control
Exercise

ClinicalTrials.gov processed this record on June 18, 2013

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