Clinical trial NCT00594048: The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension
Official title: The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: high blood pressure
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 9 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 9 weeks
measure: Diastolic Blood Pressure
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Diabetes Centre Zwolle
state: Overijssel
Study officials:
affiliation: Diabetes Centre, Isala Clinics, Zwolle
name: N. Kleefstra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Centre, Isala Clinics, Zwolle
name: S.J.J. Logtenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of General Practice, UMCG Groningen
name: K.H. Groenier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Langerhans Medical Research Group
name: S.T. Houweling, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Centre, Isala Clinics, Zwolle
name: H.J.G. Bilo, MD PhD RFCP
role: STUDY_CHAIR
References:
citation: 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.