CClinicalTrials.gg
CompletedNCT00594048Updated Oct 26, 2011

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

An interventional study of Resperate and discman with freely chosen music in Hypertension, sponsored by Medical Research Foundation, The Netherlands. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-26.

Sponsored by Medical Research Foundation, The Netherlands · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • high blood pressure
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Medical Research Foundation, The Netherlands is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device

    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

    Device: discman with freely chosen music

Interventions

  • DeviceResperate

    Use of the device 15 minutes a day for 9 weeks

    Also known as: device-guided breathing

  • Devicediscman with freely chosen music

    Use the discman 15 minutes a day for 9 weeks

06

What researchers measure

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 9 weeks

Secondary outcomes

  1. Quality of life

    Time frame: 9 weeks

  2. Diastolic Blood Pressure

    Time frame: 9 weeks

07

Study locations

1 site
  • Diabetes Centre Zwolle
    Zwolle, Overijssel, Netherlands
08

References and documents

Publications

  • 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. doi: 10.3109/08037050903272925. PubMed 19919399 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00594048
Lead sponsor
Medical Research Foundation, The Netherlands
First posted
Jan 15, 2008
Start date
Jan 2008
Primary completion
May 2008
Completion
May 2008
Last update
Oct 26, 2011

Study contacts

N. Kleefstra, MD
principal investigator · Diabetes Centre, Isala Clinics, Zwolle
S.J.J. Logtenberg, MD
principal investigator · Diabetes Centre, Isala Clinics, Zwolle
K.H. Groenier, PhD
principal investigator · University of General Practice, UMCG Groningen
S.T. Houweling, MD PhD
principal investigator · Langerhans Medical Research Group
H.J.G. Bilo, MD PhD RFCP
study chair · Diabetes Centre, Isala Clinics, Zwolle

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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