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

This study has been completed.
Sponsor:
Information provided by:
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00594048
First received: January 4, 2008
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-blind, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Other Name: device-guided breathing
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
 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
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

No publications provided by Medical Research Foundation, The Netherlands

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. dr. H.J.G. Bilo, Diabetes Centre
ClinicalTrials.gov Identifier: NCT00594048     History of Changes
Other Study ID Numbers: 07.1069, NL20147.075.07
Study First Received: January 4, 2008
Last Updated: October 25, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
high blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013