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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594048
First Posted: January 15, 2008
Last Update Posted: October 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical Research Foundation, The Netherlands
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


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

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: 9 weeks ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 9 weeks ]
  • Diastolic Blood Pressure [ Time Frame: 9 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: October 26, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases