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临床试验/NCT02681484
NCT02681484已完成不适用

Speech Guided Breathing: a Modality to Influence Cardiovascular Regulation and Health Perception in Hypertensive Patients?

Klinik Arlesheim0 个研究点目标入组 31 人开始时间: 2002年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
主要终点
Change from pre-rest baroreflex sensitivity after intervention and resting.

研究概览

简要总结

Anthroposophic speech therapy (ATS) has been shown to positively influence heart rate variability (HRV) and heart rate - respiration coordination in healthy volunteers. This study was performed to learn more about such improvements and possible alteration in baroreflex sensitivity (BRS) in hypertensive patients, which characteristically differ in those regulatory parameters from normotensive patients

详细描述

In this prospective, primarily pre-post study, patients received three ATS treatments in alternation with three control sessions (casual talking with the therapist). In order to perform HRV-analysis and BRS determination blood pressure and ECG were continuously recorded during the sessions. Changes in subjective well-being and perceived health were assessed by questionnaire before and after the various sessions (mood questionaire).

Thirty-one patients participated in this study, the majority diagnosed with arterial hypertension (22 out of 31).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Indication for speech therapy
  • Willing and able to perform speech therapy
  • Out-patient treatment or planned hospitalisation for at least 14 days.
  • Diagnosed with hypertension (I 10, either on drug therapy or verified by 24h blood pressure measurements), with tension headache (G 44.2) or with anxiety (F 41) confirmed by the recruiting physician
  • No alteration in medication affecting HRV for the last 2 months before and during the study

排除标准

  • Comorbidity strongly influencing HRV
  • Too weak to participate in an active therapy
  • Pacemaker
  • Skin disease or allergies preventing the use of ECG electrodes

结局指标

主要结局

Change from pre-rest baroreflex sensitivity after intervention and resting.

时间窗: 30min in total per session. Six sessions per patient in total.

Baro reflex sensitivity via continuous blood pressure measurement by volume clamp method (non invasive)

次要结局

  • Change from pre-rest heart rate variability after intervention and resting(Measurement over whole session (60min in total). Six sessions per patient in total.)

研究者

申办方类型
Other
责任方
Sponsor

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