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Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients

Primary Purpose

Healthy Volunteers, Hypertension, Essential

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcutaneous nervous electric stimulation (TENS)
Interferential electrical stimulation (IES)
TENS and IES Placebo
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Both sexes;
  • Normal blood pressure (PAS <130 mmHg; PAD <85 mmHg) or 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;
  • The subjects that joined the study will be alphabetized volunteers;
  • Age between 20 and 65 years old;
  • With no symptoms of skeletal muscle disorders;
  • No previous performing cardiovascular surgery;
  • No previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases;
  • Without evidence of psychiatric diseases and/or cognitive déficit;
  • Non-Smoker;
  • Volunteers with a body mass index (BMI: kg/m2) greater than 35 will not be included in the study

Exclusion Criteria:

  • On the day of the assessments who have consumed of the alcoholic drink, caffeine and citrus juice and who have performed intense physical activities 48 before the examination

Sites / Locations

  • Luis Ulisses Signori

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Transcutaneous nervous electric stimulation (TENS)

Interferential electrical stimulation (IES)

TENS and IES Placebo

Arm Description

Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after TENS. The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.

Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after Interferential electrical stimulation (IES). The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.

Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after of the TENS and IES placebo. The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.

Outcomes

Primary Outcome Measures

Systemic arterial pressure (mmHg)
Systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) (NOBRE et al., 2011). Micromed and version 5.0.1.52 equipment will be used. Blood pressure monitoring using ABPM will be performed every 10 min throughout the experiment, which has an estimated time of two hours.

Secondary Outcome Measures

Blood collection - catecholamines (pg/mL)
Plasma levels of catecholamines (dopamine, epinephrine and norepinephrine) will be evaluated before and after HPLC (High Performance Liquid Chromatography) interventions. Blood with heparin will be homogenized and immediately transferred to a special tube containing 120 μL of EGTA/GSH (reduced glutathione) solution. After being centrifuged and the plasma transferred to a plastic tube, it is placed in a freezer (-80ºC).
Heart Rate Variability (n.u.)
The autonomic balance evaluate by heart rate variability (HRV) and the heart rate signal will be purchased through a pulse frequency meter mark Polar model 810i (GAMELIN et al., 2006). The acquisition of ECG signal (sample rate-1 kHz) of the time series of RR will be purchased in continuous intervals (10 min). Data Will be transferred to a computer and RR intervals. They will be processed to calculate HRV parameter using the HRV analysis software KUBIOS. HRV will be analyzed in the time and frequency domain, using the area of greatest stability in RR intervals corresponding to 5 min of recordings (containing at least 256 consecutive beats) during controlled breathing. Volunteers Will remain in a supine position at rest for 10 min and afterwards, data will be collected with controlled breathing (12 breaths per minute; I/E:2/3) (STEIN et al., 2011). Values expressed in Total Power (ms2) and normalization unit (n.u.) (GAMELIN et al., 2006).

Full Information

First Posted
July 26, 2017
Last Updated
December 9, 2019
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT03258489
Brief Title
Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
Official Title
Effects of Transcutaneous Nervous Electric Stimulation (TENS) and Interferential Electrical Stimulation (IES) on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypertension is considered a serious public health problem. The imbalance in autonomic nervous system (ANS) activity is one of the main triggers in the development and maintenance of hypertension. The non-pharmacological management of this disease is an important resource, especially in refractory hypertensive patients or in hypertensive crises, where the pharmacological treatment does not present an efficient response. It is known that transcutaneous electrical nerve stimulation (TENS) is capable of modifying the autonomic balance, however, the effects of Interferential electrical stimulation (IES) on this system in normotensive and hypertensive volunteers are not yet known. These electrotherapeutic resources may be a non-pharmacological tool supporting the management of hypertension. The objective of this research is to study the effects of different TENS and IC parameters on cardiovascular variables of normotensive volunteers and hypertensive patients.
Detailed Description
Each volunteer will perform three assessments with a one-week interval. Each assessment will include assessment of autonomic balance, blood pressure, and blood collection (catecholamines). Interventions (placebo, low frequency TENS and IES) will be randomized. Volunteers will be accommodated in the supine position. With properly sanitized skin (70% alcohol) and self-adhesive electrodes (5x5 area) will be positioned in the cervical paravertebral region. All participants will be submitted to a placebo TENS session, a low frequency TENS session (TENS, 10 Hz/200μs) and an IES session (STEIN et al., 2012). The sessions will take place in the morning in a 12-hour fast, lasting 30 minutes, in an air-conditioned place (23ºC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Hypertension, Essential

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous nervous electric stimulation (TENS)
Arm Type
Active Comparator
Arm Description
Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after TENS. The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.
Arm Title
Interferential electrical stimulation (IES)
Arm Type
Active Comparator
Arm Description
Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after Interferential electrical stimulation (IES). The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.
Arm Title
TENS and IES Placebo
Arm Type
Placebo Comparator
Arm Description
Autonomic balance, blood pressure, and blood collection (catecholamines) will be evaluated before and after of the TENS and IES placebo. The autonomic balance will be evaluated by heart rate variability (HRV), systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) and catecholamines of kits.
Intervention Type
Device
Intervention Name(s)
Transcutaneous nervous electric stimulation (TENS)
Intervention Description
TENS (Frequency 10 Hz or 100Hz /duration 200μs, Endophasys nms 0501® model, KLD Biosystems, Amparo, SP, Brazil) will be applied with intensity between 1 to 60 mA and the current will be adjusted every 5 minutes at the sensory threshold level muscle contraction or according to the tolerance to the stimulus informed by the volunteers. TENS will be applied in bilateral paravertebral region of C7 to T4 or long the brachial plexus and sciatic plexus.
Intervention Type
Device
Intervention Name(s)
Interferential electrical stimulation (IES)
Intervention Description
The IES (Endophasys nms 0501®, KLD Biosystems, Amparo, SP, Brazil) will be applied in continuous mode with biphasic pulses. Bipolar electrodes with slope of 1/5/1. The rest of the parameters will be set to 4000 Hz, AMF of 100 Hz and the AMF variation of 25 Hz. The effect of the current will be adjusted by the intensity, it should produce paresthesia stimuli, without pain and below the motor threshold. Adhesive electrodes (MultiStick®, Axelgaard Manufacturing CO, Ltd, Fallbrook, CA, USA) will be housed in the paravertebral region, between C7 (Channel 1) and T4 (Channel 2). (SANTOS et al., 2013)
Intervention Type
Device
Intervention Name(s)
TENS and IES Placebo
Intervention Description
Same protocol without electrical output.
Primary Outcome Measure Information:
Title
Systemic arterial pressure (mmHg)
Description
Systemic arterial pressure (SBP) will be evaluated by an Ambulatory Blood Pressure Monitor (ABPM) (NOBRE et al., 2011). Micromed and version 5.0.1.52 equipment will be used. Blood pressure monitoring using ABPM will be performed every 10 min throughout the experiment, which has an estimated time of two hours.
Time Frame
SBP will be evaluated 1 hours after the interventions
Secondary Outcome Measure Information:
Title
Blood collection - catecholamines (pg/mL)
Description
Plasma levels of catecholamines (dopamine, epinephrine and norepinephrine) will be evaluated before and after HPLC (High Performance Liquid Chromatography) interventions. Blood with heparin will be homogenized and immediately transferred to a special tube containing 120 μL of EGTA/GSH (reduced glutathione) solution. After being centrifuged and the plasma transferred to a plastic tube, it is placed in a freezer (-80ºC).
Time Frame
Blood collection (catecholamines) will be evaluated 1 hours after the interventions
Title
Heart Rate Variability (n.u.)
Description
The autonomic balance evaluate by heart rate variability (HRV) and the heart rate signal will be purchased through a pulse frequency meter mark Polar model 810i (GAMELIN et al., 2006). The acquisition of ECG signal (sample rate-1 kHz) of the time series of RR will be purchased in continuous intervals (10 min). Data Will be transferred to a computer and RR intervals. They will be processed to calculate HRV parameter using the HRV analysis software KUBIOS. HRV will be analyzed in the time and frequency domain, using the area of greatest stability in RR intervals corresponding to 5 min of recordings (containing at least 256 consecutive beats) during controlled breathing. Volunteers Will remain in a supine position at rest for 10 min and afterwards, data will be collected with controlled breathing (12 breaths per minute; I/E:2/3) (STEIN et al., 2011). Values expressed in Total Power (ms2) and normalization unit (n.u.) (GAMELIN et al., 2006).
Time Frame
HRV will be evaluated 1 hours after the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both sexes; Normal blood pressure (PAS <130 mmHg; PAD <85 mmHg) or 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; The subjects that joined the study will be alphabetized volunteers; Age between 20 and 65 years old; With no symptoms of skeletal muscle disorders; No previous performing cardiovascular surgery; No previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases; Without evidence of psychiatric diseases and/or cognitive déficit; Non-Smoker; Volunteers with a body mass index (BMI: kg/m2) greater than 35 will not be included in the study Exclusion Criteria: On the day of the assessments who have consumed of the alcoholic drink, caffeine and citrus juice and who have performed intense physical activities 48 before the examination
Facility Information:
Facility Name
Luis Ulisses Signori
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
5596200190
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16672842
Citation
Gamelin FX, Berthoin S, Bosquet L. Validity of the polar S810 heart rate monitor to measure R-R intervals at rest. Med Sci Sports Exerc. 2006 May;38(5):887-93. doi: 10.1249/01.mss.0000218135.79476.9c.
Results Reference
result
PubMed Identifier
23966145
Citation
Santos FV, Chiappa GR, Vieira PJ, Umpierre D, Ribeiro JP, Cipriano G Jr. Interferential electrical stimulation improves peripheral vasodilatation in healthy individuals. Braz J Phys Ther. 2013 May-Jun;17(3):281-8. doi: 10.1590/s1413-35552012005000092.
Results Reference
result
PubMed Identifier
22262107
Citation
Sociedade Brasileira de Cardiologia (SBC); Sociedade Brasileira de Hipertensao (SBH); Sociedade Brasileira de Nefrologia (SBN). [V Guidelines for ambulatory blood pressure monitoring (ABPM) and III Guidelines for home blood pressure monitoring (HBPM)]. Arq Bras Cardiol. 2011 Sep;97(3 Suppl 3):1-24. No abstract available. Portuguese.
Results Reference
result
PubMed Identifier
21827970
Citation
Stein C, Dal Lago P, Ferreira JB, Casali KR, Plentz RD. Transcutaneous electrical nerve stimulation at different frequencies on heart rate variability in healthy subjects. Auton Neurosci. 2011 Dec 7;165(2):205-8. doi: 10.1016/j.autneu.2011.07.003. Epub 2011 Aug 9.
Results Reference
result
PubMed Identifier
23004921
Citation
Stein C, Mea Plentz RD. The effect of transcutaneous electrical nerve stimulation on blood pressure. Blood Press. 2013 Jun;22(3):188-9. doi: 10.3109/08037051.2012.722271. Epub 2012 Sep 25. No abstract available.
Results Reference
result

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Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients

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