The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension
2 other identifiers
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Jan 2008
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedOctober 26, 2011
October 1, 2011
4 months
January 4, 2008
October 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
9 weeks
Secondary Outcomes (2)
Quality of life
9 weeks
Diastolic Blood Pressure
9 weeks
Study Arms (2)
1
EXPERIMENTAL15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device
2
ACTIVE COMPARATOR15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device
Interventions
Use of the device 15 minutes a day for 9 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes Centre Zwolle
Zwolle, Overijssel, Netherlands
Related Publications (1)
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.
PMID: 19919399DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 15, 2008
Study Start
January 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
October 26, 2011
Record last verified: 2011-10