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

January 4, 2008
October 25, 2011
January 2008
May 2008   (final data collection date for primary outcome measure)
Systolic Blood Pressure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00594048 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypertension
  • Device: Resperate
    Use of the device 15 minutes a day for 9 weeks
    Other Name: device-guided breathing
  • Device: discman with freely chosen music
    Use the discman 15 minutes a day for 9 weeks
  • Experimental: 1
    15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device
    Intervention: Device: Resperate
  • 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
    Intervention: Device: discman with freely chosen music
Altena MR, Kleefstra N, Logtenberg SJ, Groenier KH, Houweling ST, Bilo HJ. Effect of device-guided breathing exercises on blood pressure in patients with hypertension: a randomized controlled trial. Blood Press. 2009;18(5):273-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00594048
07.1069, NL20147.075.07
No
Prof. dr. H.J.G. Bilo, Diabetes Centre
Medical Research Foundation, The Netherlands
Not Provided
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
Medical Research Foundation, The Netherlands
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP