HypertensionNCT00594048
The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension
A study testing Resperate and discman with freely chosen music in people with Hypertension, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Resperate and discman with freely chosen music
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Hypertension
- Being tested
- Resperate, discman with freely chosen music
- Keywords
- high blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResperateDevice
Also called device-guided breathing
Use of the device 15 minutes a day for 9 weeks
discman with freely chosen musicDevice
Use the discman 15 minutes a day for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device Receives: Device: Resperate |
| 2 | Active comparator | 15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device Receives: Device: discman with freely chosen music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: 9 weeks
Secondary outcomes (2)
Quality of life
Measured: 9 weeks
Diastolic Blood Pressure
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Investigators
- N. Kleefstra, MD, Principal investigator, Diabetes Centre, Isala Clinics, ZwolleS.J.J. Logtenberg, MD, Principal investigator, Diabetes Centre, Isala Clinics, ZwolleK.H. Groenier, PhD, Principal investigator, University of General Practice, UMCG GroningenS.T. Houweling, MD PhD, Principal investigator, Langerhans Medical Research GroupH.J.G. Bilo, MD PhD RFCP, Study chair, Diabetes Centre, Isala Clinics, Zwolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594048
- Sponsor's protocol ID
- 07.1069
- Other IDs
- NL20147.075.07
- Status last verified
- Oct 2011
- First submitted
- 4 Jan 2008
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT00594048
- Acronym / sponsor ID
- 07.1069
- Conditions
- Hypertension
- Keywords
- high blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Resperate15 hypertensive patients use the Resperate for 9 weeks and measure their blood pressure before and after using this device |
| 2 | Active comparator | Device: discman with freely chosen music15 patients use a discman with freely chosen music for 9 weeks and measure their blood pressure before and after use of this device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResperateAlso: device-guided breathingUse of the device 15 minutes a day for 9 weeks | Device | 1 |
| discman with freely chosen musicUse the discman 15 minutes a day for 9 weeks | Device | 2 |
Primary outcome
Systolic Blood Pressure
Time frame: 9 weeks
2 secondary outcomes
Quality of life
Time frame: 9 weeks
Diastolic Blood Pressure
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
- Derived from this study: PubMed 19919399Altena 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resperate and discman with freely chosen music in people with Hypertension, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011.