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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Resperate; Device: discman with freely chosen music

• Registration Number: NCT00594048
• Lead Sponsor: Medical Research Foundation, The Netherlands

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

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-25
• Last Update Posted: 2011-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Resperate	15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device
2	discman with freely chosen music	15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	9 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	9 weeks
Diastolic Blood Pressure	9 weeks

Trial Locations

Locations (1)

Diabetes Centre Zwolle; 🇳🇱 Zwolle, Overijssel, Netherlands