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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02292199 |
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Date of registration:
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12/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Transcutaneous Electrical Nerve Stimulation on Nervous System in Patients With Hypertension.
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Scientific title:
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Effects of Transcutaneous Electrical Nerve Stimulation on Sympathetic and Parasympathetic Nervous System in Patients With Hypertension: a Randomized Clinical Trial |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02292199 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Rodrigo DM Plentz, Phd |
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Address:
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Telephone:
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+55(51)9179-4399 |
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Email:
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roplentz@yahoo.com.br |
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Affiliation:
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Name:
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Sandra A Sartori, Graduated |
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Address:
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Telephone:
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+55(51)9949-6180 |
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Email:
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sandrasartorirs@gmail.com |
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Affiliation:
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Name:
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Rodrigo DM Plentz, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Health Science of Porto Alegre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Previous Hypertension diagnosis, systolic blood pressure (SBP) > 140 mm Hg and/or
diastolic blood pressure (DBP) >90 mm Hg and clinical stability with no change in
medications for at least 2 months preceding the study.
Exclusion Criteria:
Presence of any comorbidity such as diabetes; congestive heart failure; unstable angina;
myocardial infarction; acute inflammation; peripheral vascular disease; associated
neurological disease; acute respiratory illness; infectious disease or fever; cardiac
pacemaker; unstable ventricular arrhythmia; active smokers; obesity; musculoskeletal
disease in the lower limbs; changes in the electrocardiogram; smoker; treatment with beta
blockers, steroids, hormones or chemotherapy or change in drug therapy were excluded from
the study.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Intervention(s)
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Device: TENS Placebo
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Device: TENS High Frequency
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Device: TENS Low Frequency
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Primary Outcome(s)
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Heart Rate Variability
[Time Frame: 2 Hours]
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Secondary ID(s)
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HYPERTENSIONTENS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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