Decreased Vascular FlowInterMNCT01450371
Interferential Electrical Stimulation and Vasodilatation in Healthy Individuals
An observational study of Decreased Vascular Flow, run by Hospital de Clinicas de Porto Alegre at 3 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Decreased Vascular Flow
- What is being tested?
- Interferential
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 3 sitesBrazil
- Study dates
- Jul 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects without degenerative diseases.
Who may be able to join
- Subjects are non-smokers
- non-obese
- and free of any signs or symptoms of disease
Who cannot join
- Pregnancy
- breast-feeding
- alcohol or drug abuse
- medication with potential effects on cardiovascular variables
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
University of Brasilia
Brasília, Federal District
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
Gaspar Rogério da Silva Chiappa
Porto Alegre, Rio Grande do Sul, 90820-001
About this study
Official title: 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.
Read the 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.
- Conditions
- Decreased Vascular Flow
- Being tested
- Interferential, Interferential Placebo
- Keywords
- Autonomic Nervous System, Neuromodulation, Blood flow control, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterferentialDevice
Also called Transcutaenous electrical stimuation
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 PlaceboDevice
The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Interferential | |
| Placebo | The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current Receives: Device: Interferential Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Metaboreflex Reflex
Calf blood flow
Measured: Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decreased Vascular FlowStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brasilia
- Responsible party
- Principal investigator, GASPAR ROGERIO DA SILVA CHIAPPA, Principal Investigator, Hospital de Clinicas de Porto Alegre
- Investigators
- Gaspar R Chiappa, Dr, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450371
- Sponsor's protocol ID
- 11-0374
- Acronym
- InterM
- Status last verified
- Jan 2013
- First submitted
- 26 Aug 2011
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21796410
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferential Electrical Stimulation Improves Peripheral Vasodilatation in Healthy Individuals: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT01450371
- Acronym / sponsor ID
- InterM / 11-0374
- Conditions
- Decreased Vascular Flow
- Keywords
- Autonomic Nervous System, Neuromodulation, Blood flow control, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- University of Brasilia
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferential | – | Device: InterferentialThe 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). |
| Placebo | – | Device: Interferential PlaceboThe same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects without degenerative diseases.
Key inclusion criteria (3 listed)
- Subjects are non-smokers
- non-obese
- and free of any signs or symptoms of disease
Key exclusion criteria (4 listed)
- Pregnancy
- breast-feeding
- alcohol or drug abuse
- medication with potential effects on cardiovascular variables
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterferentialAlso: Transcutaenous electrical stimuationThe 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). | Device | Interferential |
| Interferential PlaceboThe same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current | Device | Placebo |
Primary outcome
Muscle Metaboreflex Reflex
Time frame: Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)
Calf blood flow
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Background: PubMed 21796410Vieira 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.
Related trials for Decreased Vascular Flow
Enrolling by invitation
Effects of Ubiquinol and Ubiquinone on Vascular Function in Healthy Adults With Borderline High LDL-Cholesterol
Borderline High LDL-cholesterol
Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
RecruitingObservational study
A Single-Center, Retrospective, Propensity-Score-Matched Cohort Study Comparing Drug-Coated Balloon Versus Drug-Eluting Stent for Reducing Immediate Post-Procedural Slow-Flow/No-Reflow in Acute ST-Elevation Myocardial Infarction Patients With High Thrombus Burden
ST Elevation Myocardial Infarction (STEMI), Acute Coronary Syndromes (ACS)
RecruitingPhase 4
A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease
No-Reflow Phenomenon, Coronary Artery Disease
RecruitingPhase 2
Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure Patients
Heart Failure With Reduced Ejection Fraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaspar R Chiappa, Dr principal investigator
Hospital de Clinicas de Porto Alegre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decreased Vascular Flow, run by Hospital de Clinicas de Porto Alegre at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Metaboreflex Reflex (time frame: Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.