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临床试验/NCT03258489
NCT03258489
已完成
不适用

Effects of Transcutaneous Nervous Electric Stimulation (TENS) and Interferential Electrical Stimulation (IES) on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients

Universidade Federal de Santa Maria1 个研究点 分布在 1 个国家目标入组 60 人2018年7月20日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Healthy Volunteers
发起方
Universidade Federal de Santa Maria
入组人数
60
试验地点
1
主要终点
Systemic arterial pressure (mmHg)
状态
已完成
最后更新
6年前

概览

简要总结

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.

详细描述

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).

注册库
clinicaltrials.gov
开始日期
2018年7月20日
结束日期
2019年12月9日
最后更新
6年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Luis Ulisses Signori

Principal Investigador

Universidade Federal de Santa Maria

入排标准

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Systemic arterial pressure (mmHg)

时间窗: 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.

次要结局

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

研究点 (1)

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