Effects of Speech-therapy in Hypertensive Patients

NCT ID: NCT02681484

Last Updated: 2016-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2008-04-30

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).

Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypertensive

Patients diagnosed with hypertension (I10, either on drug therapy or verified by 24h blood pressure measurements) administered to anthroposophic speech therapy (intervention).

Group Type EXPERIMENTAL

Anthroposophic speech therapy

Intervention Type 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.

Normotensive

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

Group Type ACTIVE_COMPARATOR

Anthroposophic speech therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Speech guided breathing therapy

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paracelsus-Spital Richterswil

UNKNOWN

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

Klinik Arlesheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Kaufmann, PhD

Role: STUDY_DIRECTOR

Chief Physician

References

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Other Identifiers

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ATS1

Identifier Type: -

Identifier Source: org_study_id

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