Effects of Speech-therapy in Hypertensive Patients

February 9, 2016 updated by: Klinik Arlesheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hypertensive
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
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.
Other Names:
  • Speech guided breathing therapy
ACTIVE_COMPARATOR: Normotensive
Patients diagnosed with tension headache (G 44.2) or anxiety disorders (F41) administered to anthroposophic speech therapy (intervention).
Behavioral: Anthroposophic speech therapy
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.
Other Names:
  • Speech guided breathing therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik Arlesheim

Collaborators

University of Bern
Paracelsus-Spital Richterswil

Investigators

  • Study Director: Christoph Kaufmann, PhD, Chief Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

February 9, 2016

First Posted (ESTIMATE)

February 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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