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Effects of Slow Breathing on Blood Pressure and Autonomic Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01390727
First Posted: July 11, 2011
Last Update Posted: May 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Decio Mion Jr., University of Sao Paulo General Hospital
  Purpose
Hypertension is a chronic disease that affects about 23% of the brazilian population. The treatment of hypertension by pharmacological intervention is efficacious, but has side effects and significant costs. Techniques that reduce the respiratory rate are shown as a effective non-pharmacological treatment in controlling blood pressure. Evidence has shown that a slow and deep breathing rate, around 10 breaths per minute or less, significantly reduces blood pressure. However, the physiological mechanisms involved in blood pressure decrease due to decreased respiratory rate are not yet known. Therefore the goals of this study will evaluate the chronic effect of breathing exercise guided on office and 24 hours blood pressure and analyse the chronic effect of breathing exercise guided over the autonomic function in hypertensive patients in stages 1 and 2.

Condition Intervention Phase
Hypertension Device: Device-guided breathing (Resperate - InterCure, Israel) Other: Listen music Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Slow Breathing on Blood Pressure and Autonomic Function in Hypertensive Patients

Further study details as provided by Decio Mion Jr., University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • blood pressure reduction [ Time Frame: 8 weeks after the randomization ]
    The blood pressure reduction in mmHg will be verified by office blood pressure measurement and ambulatory blood pressure monitoring (ABPM)


Secondary Outcome Measures:
  • autonomic regulation [ Time Frame: 8 weeks after randomization ]
    The autonomic function will be verified in the beginning and after 8 weeks from randomization as follows: muscle sympathetic nervous activity (MSNA) by microneurography technique (burst/min), plasma catecholamines levels (pg/ml) and heart rate variability by power spectral analysis (ms).


Enrollment: 32
Study Start Date: May 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Listen music
After randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks
Other: Listen music
After randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks
Active Comparator: Device-guided breathing
After randomization, the patients allocated in this arm will be instructed to use a device-guided breathing, for 15 minutes per day during 8 weeks, with the aim to reduce the respiratory frequency to less than 10 breaths/min
Device: Device-guided breathing (Resperate - InterCure, Israel)
After randomization, the patients allocated in this arm will be instructed to use a device-guided breathing, for 15 minutes per day during 8 weeks, with the aim to reduce the respiratory frequency to less than 10 breaths/min

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertensive patients with or without use of antihypertensive drug therapy with office systolic blood pressure between 140 and 179 mmHg and / or office diastolic between 90 and 109mmHg).
  • Adults over 18 years.
  • Both genders.

Exclusion Criteria:

  • Use of medications that alter sympathetic nerve activity (beta blockers and / or sympatholytics).
  • Use of three or more classes of antihypertensive drugs
  • Secondary Hypertension
  • Chronic Respiratory Disease
  • Diabetes Mellitus.
  • Chronic Kidney Disease with Clearance Creatinine <60 ml/min
  • Congestive heart failure
  • Coronary disease
  • Pregnant
  • BMI > 30 kg/m2
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390727


Locations
Brazil
General Hospital of School of Medicine - Universiy of Sao Paulo
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Decio Mion Junior, MD General Hospital of School of Medicine - University of Sao Paulo
  More Information

Responsible Party: Decio Mion Jr., MD, Phd, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01390727     History of Changes
Other Study ID Numbers: FAPESP 2010/06921-2
First Submitted: May 23, 2011
First Posted: July 11, 2011
Last Update Posted: May 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Decio Mion Jr., University of Sao Paulo General Hospital:
hypertension
device-guided breathing
autonomic function
Resperate

Additional relevant MeSH terms:
Hypertension
Respiratory Aspiration
Hypoventilation
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms


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