HypertensionNCT02608827
Sympathetic and Blood Pressure Responses to Aerobic Exercise and Guided Respiration in Hypertensives
A study testing Resperate®-InterCure Ltda and Music group (GC) in people with Hypertension, run by University of Sao Paulo General Hospital.
Trial summary
Hypertension is serious health problem in Brazil and affects almost 30%of adult population. It is known that there are pharmacologic and nonpharmacologic strategies for treating hypertension. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Resperate®-InterCure Ltda and Music group (GC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 60 years, of both sexes not obese (BMI <30 kg / m2);
- Sedentary not to perform physical exercise for at least three months;
- Hypertensive without target organ damage or untreated stage I and stage II (SBP 140-179 mmHg and DBP 90-109 mmHg) after four weeks with the use of placebo and without comorbidities; What would agree to participate in the study by signing the Instrument of Consent;
Who cannot join
- Patients who presented blood pressure greater than 180/100 mmHg at any rate during the home monitoring of blood pressure and they needed treatment with active drug;
- White-coat hypertension, or persistently elevated BP measurements (≥ 140/90 mmHg) in the office and BP means be considered normal in HBPM or ABPM.
- Masked Hypertension, or high blood pressure office <140/90 mmHg, and 24-hour ABPM with daytime BP> 130/85 mmHg;
- Patients with a history of alcoholism, drug abuse or mental disorders that could invalidate the consent, or limit the patient's ability to comply with the rules of the Protocol
About this study
Hypertension is serious health problem in Brazil and affects almost 30%of adult population. It is known that there are pharmacologic and nonpharmacologic strategies for treating hypertension. Aerobic exercise and slow breathing are nonpharmacologic methods that reduce blood pressure in an isolated form, but its combinations has never been studied. The aim of this study is to evaluate the association of both strategies and also the mechanisms involved in blood pressure reduction using slow breathing, in stages 1 and 2 hypertensives.
Read the detailed description
The combination of drugs and no medication for hypertension treatment has been widely recommended, with emphasis on aerobic exercises (EXE), relaxation exercises, and the use of equipment designed to decrease the respiratory rate called Resperate®. This intervention has demonstrated a hypotensive effect in pressure measurements in clinical blood pressure and ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM). It is unknown; however, if slow breathing (GRL) associated with other intervention, such as EXE, for example, may potentiate the blood pressure (BP) reduction. The aim of this study will be evaluate the acute responses of muscle sympathetic nerve activity (MSNA) and BP, in association of the slow breathing versus control (listening to calm music) and the 24 hour blood pressure response after the association of EXE and GRL. Twenty hypertensives will be evaluated between 18 to 60 years old, mens and woman, sedentary, non-obese, without target organs damage and associated comorbidities, after 4 weeks of placebo use (washout period). Participants will be randomly divided into 2 groups (GRL and GC) and both perform EXE on a cycle ergometer. Volunteers will make a ABPM before and after the experimental session. In this session will be recorded for 10 minutes, prior to the physical exercise, the systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR) and heart rate (HR), after that, It will be held microneurography to register also the MSNA for 10 minutes, then they will perform either GRL or listened to music for 15 minutes. Variables will be measures for more 10 minutes. After finishing the session, volunteers will put the ABPM and will go away.
- Conditions
- Hypertension
- Being tested
- Resperate®-InterCure Ltda, Music group (GC)
- Keywords
- Hypertension; slow breathing; sympathetic nerve activity
- Medical subject headings
- Hypertension, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resperate®-InterCure LtdaDevice
The device-guided breathing - Resperate®-InterCure Ltda, uses sound to guide and therefore reduce the respiration rate in individuals.
Music group (GC)Other
The patients in this arm will hear slow music - Music group (GC).
| Study group | Role | What they receive |
|---|---|---|
| Slow breathing group (GRL) | Active comparator | After randomization and have done aerobic exercise, patients allocated in this arm of the study, using the device-guided breathing - Slow breathing group (GRL), for 15 minutes during the experimental session. Receives: Device: Resperate®-InterCure Ltda |
| Music group (GC) | Placebo comparator | After randomization and have done aerobic exercise, patients allocated in this study arm will hear slow music - Music group (GC), for 15 minutes during the experimental session. Receives: Other: Music group (GC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reduction
The reduction in blood pressure in mmHg immediately after after a single session of the association of aerobic exercise and guided slow breathing and during 24 hours blood pressure monitoring (ABPM).
Measured: A session (1 day), after the placebo period of 30 days.
Secondary outcomes (1)
Autonomic regulation
The sympathetic nerve activity will be measured by microneurography technique (burst/min), after a single session of bike aerobic exercise and slow breathing with a guided device.
Measured: A session (1 day), after the placebo period of 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Goveia de Araújo, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608827
- Sponsor's protocol ID
- FAPESP 2010/11413-6
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic and Blood Pressure Responses to Aerobic Exercise and Guided Respiration in Hypertensives
- ClinicalTrials.gov ID
- NCT02608827
- Acronym / sponsor ID
- FAPESP 2010/11413-6
- Conditions
- Hypertension
- Keywords
- Hypertension; slow breathing; sympathetic nerve activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Nov 2015 (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.
Hypertension is serious health problem in Brazil and affects almost 30%of adult population. It is known that there are pharmacologic and nonpharmacologic strategies for treating hypertension. Aerobic exercise and slow breathing are nonpharmacologic methods that reduce blood pressure in an isolated form, but its combinations has never been studied. The aim of this study is to evaluate the association of both strategies and also the mechanisms involved in blood pressure reduction using slow breathing, in stages 1 and 2 hypertensives.
Detailed description
The combination of drugs and no medication for hypertension treatment has been widely recommended, with emphasis on aerobic exercises (EXE), relaxation exercises, and the use of equipment designed to decrease the respiratory rate called Resperate®. This intervention has demonstrated a hypotensive effect in pressure measurements in clinical blood pressure and ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM). It is unknown; however, if slow breathing (GRL) associated with other intervention, such as EXE, for example, may potentiate the blood pressure (BP) reduction. The aim of this study will be evaluate the acute responses of muscle sympathetic nerve activity (MSNA) and BP, in association of the slow breathing versus control (listening to calm music) and the 24 hour blood pressure response after the association of EXE and GRL. Twenty hypertensives will be evaluated between 18 to 60 years old, mens and woman, sedentary, non-obese, without target organs damage and associated comorbidities, after 4 weeks of placebo use (washout period). Participants will be randomly divided into 2 groups (GRL and GC) and both perform EXE on a cycle ergometer. Volunteers will make a ABPM before and after the experimental session. In this session will be recorded for 10 minutes, prior to the physical exercise, the systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR) and heart rate (HR), after that, It will be held microneurography to register also the MSNA for 10 minutes, then they will perform either GRL or listened to music for 15 minutes. Variables will be measures for more 10 minutes. After finishing the session, volunteers will put the ABPM and will go away.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow breathing group (GRL) | Active comparator | Device: Resperate®-InterCure LtdaAfter randomization and have done aerobic exercise, patients allocated in this arm of the study, using the device-guided breathing - Slow breathing group (GRL), for 15 minutes during the experimental session. |
| Music group (GC) | Placebo comparator | Other: Music group (GC)After randomization and have done aerobic exercise, patients allocated in this study arm will hear slow music - Music group (GC), for 15 minutes during the experimental session. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 60 years, of both sexes not obese (BMI <30 kg / m2);
- Sedentary not to perform physical exercise for at least three months;
- Hypertensive without target organ damage or untreated stage I and stage II (SBP 140-179 mmHg and DBP 90-109 mmHg) after four weeks with the use of placebo and without comorbidities; What would agree to participate in the study by signing the Instrument of Consent;
Key exclusion criteria (4 listed)
- Patients who presented blood pressure greater than 180/100 mmHg at any rate during the home monitoring of blood pressure and they needed treatment with active drug;
- White-coat hypertension, or persistently elevated BP measurements (≥ 140/90 mmHg) in the office and BP means be considered normal in HBPM or ABPM.
- Masked Hypertension, or high blood pressure office <140/90 mmHg, and 24-hour ABPM with daytime BP> 130/85 mmHg;
- Patients with a history of alcoholism, drug abuse or mental disorders that could invalidate the consent, or limit the patient's ability to comply with the rules of the Protocol
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 |
|---|---|---|
| Resperate®-InterCure LtdaThe device-guided breathing - Resperate®-InterCure Ltda, uses sound to guide and therefore reduce the respiration rate in individuals. | Device | Slow breathing group (GRL) |
| Music group (GC)The patients in this arm will hear slow music - Music group (GC). | Other | Music group (GC) |
Primary outcome
Blood pressure reduction
Time frame: A session (1 day), after the placebo period of 30 days.
The reduction in blood pressure in mmHg immediately after after a single session of the association of aerobic exercise and guided slow breathing and during 24 hours blood pressure monitoring (ABPM).
1 secondary outcome
Autonomic regulation
Time frame: A session (1 day), after the placebo period of 30 days.
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 27 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Resperate®-InterCure Ltda and Music group (GC) in people with Hypertension, run by University of Sao Paulo General Hospital.
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 3 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Blood pressure reduction (time frame: A session (1 day), after the placebo period of 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2016.