Effects of Speech-therapy in Hypertensive Patients

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Anthroposophic speech therapy

• Registration Number: NCT02681484
• Lead Sponsor: Klinik Arlesheim

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2015-10-30
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-09
• Last Update Submitted: 2016-02-09
• Study First Posted: 2016-02-12
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Hypertensive	Anthroposophic speech therapy	Patients diagnosed with hypertension (I10, either on drug therapy or verified by 24h blood pressure measurements) administered to anthroposophic speech therapy (intervention).
Normotensive	Anthroposophic speech therapy	Patients diagnosed with tension headache (G 44.2) or anxiety disorders (F41) administered to anthroposophic speech therapy (intervention).

Primary Outcome Measures

Name	Time	Method
Change from pre-rest baroreflex sensitivity after intervention and resting.	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)

Secondary Outcome Measures

Name	Time	Method
Change from pre-rest heart rate variability after intervention and resting	Measurement over whole session (60min in total). Six sessions per patient in total.	Heart rate variability measurements via portable ECG-recorder