Effects of Speech-therapy in Hypertensive Patients

A study testing Anthroposophic speech therapy in people with Hypertension, run by Klinik Arlesheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Hypertension
What is being tested?: Anthroposophic speech therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: No sites listed yet
Study dates: Sep 2002to Apr 2008
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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).

Conditions: Hypertension
Being tested: Anthroposophic speech therapy
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anthroposophic speech therapyBehavioural
Also called Speech guided breathing 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.

Study groups in NCT02681484
Study group	Role	What they receive
Hypertensive	Experimental	Patients diagnosed with hypertension (I10, either on drug therapy or verified by 24h blood pressure measurements) administered to anthroposophic speech therapy (intervention). Receives: 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). Receives: Behavioral: Anthroposophic speech therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from pre-rest baroreflex sensitivity after intervention and resting.
Baro reflex sensitivity via continuous blood pressure measurement by volume clamp method (non invasive)
Measured: 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
Heart rate variability measurements via portable ECG-recorder
Measured: Measurement over whole session (60min in total). Six sessions per patient in total.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2002Apr 2008

First posted12 Feb 2016 (estimated)
Study startSep 2002
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02681484
Sponsor's protocol ID: ATS1
Status last verified: Feb 2016
First submitted: 30 Oct 2015
Last updated: 12 Feb 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Simoes-Wust AP, Rist L, Dettling M. Self-reported health characteristics and medication consumption by CAM users and nonusers: a Swiss cross-sectional survey. J Altern Complement Med. 2014 Jan;20(1):40-7. doi: 10.1089/acm.2012.0762. Epub 2013 Jul 17.
PubMed 23863087
Brook RD, Appel LJ, Rubenfire M, Ogedegbe G, Bisognano JD, Elliott WJ, Fuchs FD, Hughes JW, Lackland DT, Staffileno BA, Townsend RR, Rajagopalan S; American Heart Association Professional Education Committee of the Council for High Blood Pressure Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, and Council on Nutrition, Physical Activity. Beyond medications and diet: alternative approaches to lowering blood pressure: a scientific statement from the american heart association. Hypertension. 2013 Jun;61(6):1360-83. doi: 10.1161/HYP.0b013e318293645f. Epub 2013 Apr 22.
PubMed 23608661
Mancia G, Grassi G, Giannattasio C, Seravalle G. Sympathetic activation in the pathogenesis of hypertension and progression of organ damage. Hypertension. 1999 Oct;34(4 Pt 2):724-8. doi: 10.1161/01.hyp.34.4.724.
PubMed 10523349
Mancia G, Grassi G. Mechanisms and clinical implications of blood pressure variability. J Cardiovasc Pharmacol. 2000;35(7 Suppl 4):S15-9. doi: 10.1097/00005344-200000004-00003.
PubMed 11346215
Jonas WB. Reframing placebo in research and practice. Philos Trans R Soc Lond B Biol Sci. 2011 Jun 27;366(1572):1896-904. doi: 10.1098/rstb.2010.0405.
PubMed 21576147
Bernardi L, Sleight P, Bandinelli G, Cencetti S, Fattorini L, Wdowczyc-Szulc J, Lagi A. Effect of rosary prayer and yoga mantras on autonomic cardiovascular rhythms: comparative study. BMJ. 2001 Dec 22-29;323(7327):1446-9. doi: 10.1136/bmj.323.7327.1446.
PubMed 11751348
Cysarz D, von Bonin D, Brachmann P, Buetler S, Edelhauser F, Laederach-Hofmann K, Heusser P. Day-to-night time differences in the relationship between cardiorespiratory coordination and heart rate variability. Physiol Meas. 2008 Nov;29(11):1281-91. doi: 10.1088/0967-3334/29/11/004. Epub 2008 Oct 9.
PubMed 18843164
von Bonin D, Grote V, Buri C, Cysarz D, Heusser P, Moser M, Wolf U, Laederach K. Adaption of cardio-respiratory balance during day-rest compared to deep sleep--an indicator for quality of life? Psychiatry Res. 2014 Nov 30;219(3):638-44. doi: 10.1016/j.psychres.2014.06.004. Epub 2014 Jun 9.
PubMed 25011731
Villa MP, Calcagnini G, Pagani J, Paggi B, Massa F, Ronchetti R. Effects of sleep stage and age on short-term heart rate variability during sleep in healthy infants and children. Chest. 2000 Feb;117(2):460-6. doi: 10.1378/chest.117.2.460.
PubMed 10669691
Sztajzel J. Heart rate variability: a noninvasive electrocardiographic method to measure the autonomic nervous system. Swiss Med Wkly. 2004 Sep 4;134(35-36):514-22. doi: 10.4414/smw.2004.10321.
PubMed 15517504
Berntson GG, Bigger JT Jr, Eckberg DL, Grossman P, Kaufmann PG, Malik M, Nagaraja HN, Porges SW, Saul JP, Stone PH, van der Molen MW. Heart rate variability: origins, methods, and interpretive caveats. Psychophysiology. 1997 Nov;34(6):623-48. doi: 10.1111/j.1469-8986.1997.tb02140.x.
PubMed 9401419
Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
PubMed 8737210
Oka H, Mochio S, Yoshioka M, Morita M, Inoue K. Evaluation of baroreflex sensitivity by the sequence method using blood pressure oscillations and R-R interval changes during deep respiration. Eur Neurol. 2003;50(4):230-43. doi: 10.1159/000073865.
PubMed 14634268
Walchli C, Saltzwedel G, Kruerke D, Kaufmann C, Schnorr B, Rist L, Eberhard J, Decker M, Simoes-Wust AP. Physiologic effects of rhythmical massage: a prospective exploratory cohort study. J Altern Complement Med. 2014 Jun;20(6):507-15. doi: 10.1089/acm.2012.0833. Epub 2013 May 23.
PubMed 23700977
Seifert G, Driever PH, Pretzer K, Edelhauser F, Bach S, Laue HB, Langler A, Musial-Bright L, Henze G, Cysarz D. Effects of complementary eurythmy therapy on heart rate variability. Complement Ther Med. 2009 Jun;17(3):161-7. doi: 10.1016/j.ctim.2008.09.005. Epub 2008 Nov 20.
PubMed 19398070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Speech Guided Breathing: a Modality to Influence Cardiovascular Regulation and Health Perception in Hypertensive Patients?
ClinicalTrials.gov ID: NCT02681484
Acronym / sponsor ID: ATS1
Conditions: Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Klinik ArlesheimUniversity, hospital or other
Collaborators: Paracelsus-Spital Richterswil, University of Bern
Study start: Sep 2002
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 12 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Thirty-one patients participated in this study, the majority diagnosed with arterial hypertension (22 out of 31).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hypertensive	Experimental	Behavioral: Anthroposophic speech therapyPatients diagnosed with hypertension (I10, either on drug therapy or verified by 24h blood pressure measurements) administered to anthroposophic speech therapy (intervention).
Normotensive	Active comparator	Behavioral: Anthroposophic speech therapyPatients diagnosed with tension headache (G 44.2) or anxiety disorders (F41) administered to anthroposophic speech therapy (intervention).

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anthroposophic speech therapyAlso: Speech guided breathing therapyAnthroposophic 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.	Behavioural	Hypertensive, Normotensive

Primary outcome

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)

1 secondary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
Background: PubMed 23863087Simoes-Wust AP, Rist L, Dettling M. Self-reported health characteristics and medication consumption by CAM users and nonusers: a Swiss cross-sectional survey. J Altern Complement Med. 2014 Jan;20(1):40-7. doi: 10.1089/acm.2012.0762. Epub 2013 Jul 17.
Background: PubMed 23608661Brook RD, Appel LJ, Rubenfire M, Ogedegbe G, Bisognano JD, Elliott WJ, Fuchs FD, Hughes JW, Lackland DT, Staffileno BA, Townsend RR, Rajagopalan S; American Heart Association Professional Education Committee of the Council for High Blood Pressure Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, and Council on Nutrition, Physical Activity. Beyond medications and diet: alternative approaches to lowering blood pressure: a scientific statement from the american heart association. Hypertension. 2013 Jun;61(6):1360-83. doi: 10.1161/HYP.0b013e318293645f. Epub 2013 Apr 22.
Background: PubMed 10523349Mancia G, Grassi G, Giannattasio C, Seravalle G. Sympathetic activation in the pathogenesis of hypertension and progression of organ damage. Hypertension. 1999 Oct;34(4 Pt 2):724-8. doi: 10.1161/01.hyp.34.4.724.
Background: PubMed 11346215Mancia G, Grassi G. Mechanisms and clinical implications of blood pressure variability. J Cardiovasc Pharmacol. 2000;35(7 Suppl 4):S15-9. doi: 10.1097/00005344-200000004-00003.
Background: PubMed 21576147Jonas WB. Reframing placebo in research and practice. Philos Trans R Soc Lond B Biol Sci. 2011 Jun 27;366(1572):1896-904. doi: 10.1098/rstb.2010.0405.
Background: PubMed 11751348Bernardi L, Sleight P, Bandinelli G, Cencetti S, Fattorini L, Wdowczyc-Szulc J, Lagi A. Effect of rosary prayer and yoga mantras on autonomic cardiovascular rhythms: comparative study. BMJ. 2001 Dec 22-29;323(7327):1446-9. doi: 10.1136/bmj.323.7327.1446.
Background: PubMed 18843164Cysarz D, von Bonin D, Brachmann P, Buetler S, Edelhauser F, Laederach-Hofmann K, Heusser P. Day-to-night time differences in the relationship between cardiorespiratory coordination and heart rate variability. Physiol Meas. 2008 Nov;29(11):1281-91. doi: 10.1088/0967-3334/29/11/004. Epub 2008 Oct 9.
Background: PubMed 25011731von Bonin D, Grote V, Buri C, Cysarz D, Heusser P, Moser M, Wolf U, Laederach K. Adaption of cardio-respiratory balance during day-rest compared to deep sleep--an indicator for quality of life? Psychiatry Res. 2014 Nov 30;219(3):638-44. doi: 10.1016/j.psychres.2014.06.004. Epub 2014 Jun 9.
Background: PubMed 10669691Villa MP, Calcagnini G, Pagani J, Paggi B, Massa F, Ronchetti R. Effects of sleep stage and age on short-term heart rate variability during sleep in healthy infants and children. Chest. 2000 Feb;117(2):460-6. doi: 10.1378/chest.117.2.460.
Background: PubMed 15517504Sztajzel J. Heart rate variability: a noninvasive electrocardiographic method to measure the autonomic nervous system. Swiss Med Wkly. 2004 Sep 4;134(35-36):514-22. doi: 10.4414/smw.2004.10321.
Background: PubMed 9401419Berntson GG, Bigger JT Jr, Eckberg DL, Grossman P, Kaufmann PG, Malik M, Nagaraja HN, Porges SW, Saul JP, Stone PH, van der Molen MW. Heart rate variability: origins, methods, and interpretive caveats. Psychophysiology. 1997 Nov;34(6):623-48. doi: 10.1111/j.1469-8986.1997.tb02140.x.
Background: PubMed 8737210Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
Individual participant dataSharing planned: No

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Chronic Kidney Disease, Hypertension (HTN)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christoph Kaufmann, PhD study director

Chief Physician

Questions about this trial

What is this clinical trial studying?

A study testing Anthroposophic speech therapy in people with Hypertension, run by Klinik Arlesheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from pre-rest baroreflex sensitivity after intervention and resting. (time frame: 30min in total per session. Six sessions per patient in total.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02681484, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.