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The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension

NCT ID: NCT00594048

Last Updated: 2011-10-26

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine whether breathing-exercises with the Resperate or listening to a discman with freely chosen music are effective in the treatment of hypertension

Detailed Description

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Hypertension is an important risk factor for the development of macrovascular events. Lowering blood pressure leads to a reduced risk of developing these complications. To treat hypertension effectively you can use blood pressure lowering drugs, but it is also important to use proven and safe non-pharmacological interventions. It is suggested that Breathing Rate and Systolic Blood Pressure can be linked directly together by the baroreflex. With the use of the Resperate, people will lower their breathing rate by breathing similar to music patterns which could theoretically lead, through the described link, to blood pressure reduction. Patients will be randomize into two groups: one will get a discman with freely chosen music and the other the Resperate. Patients are instructed to use the breathing device or discman for 15 minutes at about the same time every day during the 9 week study period, except for the first week.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device

Group Type EXPERIMENTAL

Resperate

Intervention Type DEVICE

Use of the device 15 minutes a day for 9 weeks

2

15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device

Group Type ACTIVE_COMPARATOR

discman with freely chosen music

Intervention Type DEVICE

Use the discman 15 minutes a day for 9 weeks

Interventions

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Resperate

Use of the device 15 minutes a day for 9 weeks

Intervention Type DEVICE

discman with freely chosen music

Use the discman 15 minutes a day for 9 weeks

Intervention Type DEVICE

Other Intervention Names

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device-guided breathing

Eligibility Criteria

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Inclusion Criteria

* Over 18 years old
* Known hypertension with a SBP between 130-170 mmHg at previous visit to the internal outpatient department and at the last visit to the internist
* Treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months
* At Baseline the SBP should be between 140-160 mmHg

Exclusion Criteria

* Patients with known diabetes
* Patients with heart failure (NYHA III-IV)
* Patients with pulmonary disease
* Patients with insufficient knowledge of the Dutch language to understand the requirements of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Foundation, The Netherlands

OTHER

Sponsor Role lead

Responsible Party

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Diabetes Centre

Principal Investigators

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N. Kleefstra, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Centre, Isala Clinics, Zwolle

S.J.J. Logtenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Centre, Isala Clinics, Zwolle

K.H. Groenier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of General Practice, UMCG Groningen

S.T. Houweling, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Langerhans Medical Research Group

H.J.G. Bilo, MD PhD RFCP

Role: STUDY_CHAIR

Diabetes Centre, Isala Clinics, Zwolle

Locations

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Diabetes Centre Zwolle

Zwolle, Overijssel, Netherlands

Site Status

Countries

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Netherlands

References

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Altena MR, Kleefstra N, Logtenberg SJ, Groenier KH, Houweling ST, Bilo HJ. Effect of device-guided breathing exercises on blood pressure in patients with hypertension: a randomized controlled trial. Blood Press. 2009;18(5):273-9. doi: 10.3109/08037050903272925.

Reference Type DERIVED
PMID: 19919399 (View on PubMed)

Other Identifiers

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NL20147.075.07

Identifier Type: -

Identifier Source: secondary_id

07.1069

Identifier Type: -

Identifier Source: org_study_id