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Sponsored by: |
Medical Research Foundation, The Netherlands |
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Information provided by: | Medical Research Foundation, The Netherlands |
ClinicalTrials.gov Identifier: | NCT00594048 |
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
Condition | Intervention |
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Hypertension |
Device: Resperate Device: discman with freely chosen music |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | The Effects of Device-Guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-Blind, Controlled Trial |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device
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Device: Resperate
Use of the device 15 minutes a day for 9 weeks
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2: Active Comparator
15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device
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Device: discman with freely chosen music
Use the discman 15 minutes a day for 9 weeks
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands, Overijssel | |
Diabetes Centre Zwolle | |
Zwolle, Overijssel, Netherlands |
Principal Investigator: | N. Kleefstra, MD | Diabetes Centre, Isala Clinics, Zwolle |
Principal Investigator: | S.J.J. Logtenberg, MD | Diabetes Centre, Isala Clinics, Zwolle |
Principal Investigator: | K.H. Groenier, PhD | University of General Practice, UMCG Groningen |
Principal Investigator: | S.T. Houweling, MD PhD | Langerhans Medical Research Group |
Study Chair: | H.J.G. Bilo, MD PhD RFCP | Diabetes Centre, Isala Clinics, Zwolle |
Responsible Party: | Diabetes Centre ( Prof. dr. H.J.G. Bilo ) |
Study ID Numbers: | 07.1069, NL20147.075.07 |
Study First Received: | January 4, 2008 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00594048 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
high blood pressure |
Vascular Diseases Hypertension |
Cardiovascular Diseases |