The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension
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| First Received Date ICMJE | January 4, 2008 | ||||||||||||||||||||
| Last Updated Date | October 25, 2011 | ||||||||||||||||||||
| Start Date ICMJE | January 2008 | ||||||||||||||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Systolic Blood Pressure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00594048 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension | ||||||||||||||||||||
| Official Title ICMJE | The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-blind, Controlled Trial | ||||||||||||||||||||
| Brief Summary | 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 |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Hypertension | ||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||||||||||||||
| Completion Date | May 2008 | ||||||||||||||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | Netherlands | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT00594048 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | 07.1069, NL20147.075.07 | ||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||
| Responsible Party | Prof. dr. H.J.G. Bilo, Diabetes Centre | ||||||||||||||||||||
| Study Sponsor ICMJE | Medical Research Foundation, The Netherlands | ||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Medical Research Foundation, The Netherlands | ||||||||||||||||||||
| Verification Date | October 2011 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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