The Effects of Device-Guided Breathing Exercises on Blood Pressure in Patients With Hypertension - Full Text View

Sponsored by:	Medical Research Foundation, The Netherlands
Information provided by:	Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:	NCT00594048

Purpose

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

Condition	Intervention
Hypertension	Device: Resperate Device: discman with freely chosen music

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Device-Guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-Blind, Controlled Trial

Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:

Systolic Blood Pressure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Diastolic Blood Pressure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device	Device: Resperate Use of the device 15 minutes a day for 9 weeks
2: Active Comparator 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 Use the discman 15 minutes a day for 9 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594048

Locations

Netherlands, Overijssel
Diabetes Centre Zwolle
Zwolle, Overijssel, Netherlands

Sponsors and Collaborators

Medical Research Foundation, The Netherlands

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

More Information

Responsible Party:	Diabetes Centre ( Prof. dr. H.J.G. Bilo )
Study ID Numbers:	07.1069, NL20147.075.07
Study First Received:	January 4, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00594048
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:

high blood pressure

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009