- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450371
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
Conditions
Intervention / Treatment
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
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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:
|
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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