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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594048
• Other study ID #: 07.1069
• Secondary ID: NL20147.075.07
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: October 25, 2011
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: October 2011
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Resperate
Use of the device 15 minutes a day for 9 weeks
• discman with freely chosen music
Use the discman 15 minutes a day for 9 weeks

Locations

Country	Name	City	State
Netherlands	Diabetes Centre Zwolle	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure		9 weeks	No
Secondary	Quality of life		9 weeks	No
Secondary	Diastolic Blood Pressure		9 weeks	No