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

Not Applicable

Completed

• Conditions: Hypertension, Essential; Healthy Volunteers
• Interventions: Device: Interferential electrical stimulation (IES); Device: Transcutaneous nervous electric stimulation (TENS); Device: TENS and IES Placebo

• Registration Number: NCT03258489
• Lead Sponsor: Universidade Federal de Santa Maria

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).

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-23
• Study Start: 2018-07-20
• Status Verified: 2019-12
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Interferential electrical stimulation (IES)	Interferential electrical stimulation (IES)	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.
Transcutaneous nervous electric stimulation (TENS)	Transcutaneous nervous electric stimulation (TENS)	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.
TENS and IES Placebo	TENS and IES Placebo	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.

Primary Outcome Measures

Name	Time	Method
Systemic arterial pressure (mmHg)	SBP will be evaluated 1 hours after the interventions	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

Name	Time	Method
Heart Rate Variability (n.u.)	HRV will be evaluated 1 hours after the interventions	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).
Blood collection - catecholamines (pg/mL)	Blood collection (catecholamines) will be evaluated 1 hours after the interventions	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).

Trial Locations

Locations (1)

Luis Ulisses Signori; 🇧🇷 Santa Maria, Rio Grande Do Sul, Brazil