Effects of Speech-therapy in Hypertensive Patients

NCT02681484 | Completed

• 1 other identifier: ATS1
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from pre-rest heart rate variability after intervention and resting

  Measurement over whole session (60min in total). Six sessions per patient in total.

Study Arms (2)

Hypertensive

EXPERIMENTAL

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

Normotensive

ACTIVE COMPARATOR

Patients diagnosed with tension headache (G 44.2) or anxiety disorders (F41) administered to anthroposophic speech therapy (intervention).

Behavioral: Anthroposophic speech therapy

Interventions

Anthroposophic speech therapy BEHAVIORAL

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.

Also known as: Speech guided breathing therapy

Hypertensive; Normotensive

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Klinik Arlesheim: lead
• Paracelsus-Spital Richterswil: collaborator
• University of Bern: collaborator

Related Publications (23)

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christoph Kaufmann, PhD

  Chief Physician

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: February 12, 2016
• Study Start: September 1, 2002
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 12, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share