Interferential Electrical Stimulation and Vasodilatation in Healthy Individuals

Decreased Vascular Flow Clinical Trial

— InterM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450371
• Other study ID #: 11-0374
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: January 23, 2013
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Decreased Vascular Flow

Intervention

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

Locations

Country	Name	City	State
Brazil	University of Brasilia	Brasilia	DF
Brazil	Gaspar Rogério da Silva Chiappa	Porto Alegre	RS
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	University of Brasilia

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Metaboreflex Reflex	Calf blood flow	Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)	Yes