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

Medical Research Foundation, The Netherlands

Status: Completed

Conditions: Hypertension

Treatments: Device: Resperate; Device: discman with freely chosen music

Study type: Interventional

Funder types: Other

Identifiers

NCT00594048

07.1069

NL20147.075.07

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Device: Resperate

2

Active Comparator group

Description:

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

Treatment:

Device: discman with freely chosen music