The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension
October 25, 2011 updated by: Medical Research Foundation, The Netherlands
The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-blind, Controlled Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Overijssel
-
Zwolle, Overijssel, Netherlands
- Diabetes Centre Zwolle
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device
|
Use of the device 15 minutes a day for 9 weeks
Other Names:
|
|
Active Comparator: 2
15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device
|
Use the discman 15 minutes a day for 9 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Systolic Blood Pressure
Time Frame: 9 weeks
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: 9 weeks
|
9 weeks
|
|
Diastolic Blood Pressure
Time Frame: 9 weeks
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: N. Kleefstra, MD, Diabetes Centre, Isala Clinics, Zwolle
- Principal Investigator: S.J.J. Logtenberg, MD, Diabetes Centre, Isala Clinics, Zwolle
- Principal Investigator: K.H. Groenier, PhD, University of General Practice, UMCG Groningen
- Principal Investigator: S.T. Houweling, MD PhD, Langerhans Medical Research Group
- Study Chair: H.J.G. Bilo, MD PhD RFCP, Diabetes Centre, Isala Clinics, Zwolle
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
January 4, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
October 26, 2011
Last Update Submitted That Met QC Criteria
October 25, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07.1069
- NL20147.075.07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.