Effects of Speech-therapy in Hypertensive Patients

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Anthroposophic speech therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertensive<br>Patients diagnosed with hypertension (I10, either on drug therapy or verified by 24h blood pressure measurements) administered to anthroposophic speech therapy (intervention). | Behavioral: Anthroposophic speech therapy<br>* Anthroposophic speech therapy uses sound-combinations like KLSFM or OM and hexameter verse in German, spoken by the therapist and imitated by the patients, to expand and decelerate respiration. The intervention is conducted by the same qualified therapist for one patient in different days but during the same daytime for 30 minutes in upright position and walking.<br>* Other names: Speech guided breathing therapy;|
| Active Comparator: Normotensive<br>Patients diagnosed with tension headache (G 44.2) or anxiety disorders (F41) administered to anthroposophic speech therapy (intervention). | Behavioral: Anthroposophic speech therapy<br>* Anthroposophic speech therapy uses sound-combinations like KLSFM or OM and hexameter verse in German, spoken by the therapist and imitated by the patients, to expand and decelerate respiration. The intervention is conducted by the same qualified therapist for one patient in different days but during the same daytime for 30 minutes in upright position and walking.<br>* Other names: Speech guided breathing therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pre-rest baroreflex sensitivity after intervention and resting. | Baro reflex sensitivity via continuous blood pressure measurement by volume clamp method (non invasive) | 30min in total per session. Six sessions per patient in total. | 

Secondary Outcome Measures

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