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

Study Overview
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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.

Official Title
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The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-blind, Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Device: Resperate
* Device: discman with freely chosen music


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device | Device: Resperate<br>* Use of the device 15 minutes a day for 9 weeks<br>* Other names: device-guided breathing;|
| Active Comparator: 2<br>15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device | Device: discman with freely chosen music<br>* Use the discman 15 minutes a day for 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 9 weeks | 
| Diastolic Blood Pressure |  | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high blood pressure