Clinical trial NCT02681484: Effects of Speech-therapy in Hypertensive Patients
Official title: Speech Guided Breathing: a Modality to Influence Cardiovascular Regulation and Health Perception in Hypertensive Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Klinik Arlesheim
Sponsor class: OTHER
Collaborators: name: Paracelsus-Spital Richterswil
name: University of Bern
First posted: 2016-02-12
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from pre-rest baroreflex sensitivity after intervention and resting.
timeFrame: 30min in total per session. Six sessions per patient in total.
Secondary outcomes:
measure: Change from pre-rest heart rate variability after intervention and resting
timeFrame: Measurement over whole session (60min in total). Six sessions per patient in total.
Other outcomes:
Locations:
Study officials:
affiliation: Chief Physician
name: Christoph Kaufmann, PhD
role: STUDY_DIRECTOR
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