Clincosm LogoSign in Get a demo

Effects of Speech-therapy in Hypertensive Patients

Sponsor
Klinik Arlesheim (Other)
Overall Status
Completed
CT.gov ID
NCT02681484
Collaborator
Paracelsus-Spital Richterswil (Other), University of Bern (Other)
31
Enrollment
2
Arms
67
Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Anthroposophic speech therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Speech Guided Breathing: a Modality to Influence Cardiovascular Regulation and Health Perception in Hypertensive Patients?
Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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.]

      Heart rate variability measurements via portable ECG-recorder

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Klinik Arlesheim
    • Paracelsus-Spital Richterswil
    • University of Bern

    Investigators

    • Study Director: Christoph Kaufmann, PhD, Chief Physician

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Klinik Arlesheim
    ClinicalTrials.gov Identifier:
    NCT02681484
    Other Study ID Numbers:
    • ATS1
    First Posted:
    Feb 12, 2016
    Last Update Posted:
    Feb 12, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Feb 12, 2016