Effects of Slow Breathing on Blood Pressure and Autonomic Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Fundação de Amparo à Pesquisa do Estado de São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundação de Amparo à Pesquisa do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01390727
First received: May 23, 2011
Last updated: July 8, 2011
Last verified: May 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Slow Breathing on Blood Pressure and Autonomic Function in Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Fundação de Amparo à Pesquisa do Estado de São Paulo:

Primary Outcome Measures:
  • blood pressure reduction [ Time Frame: 8 weeks after the randomization ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 32
Study Start Date: May 2011
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390727

Contacts
Contact: Silvana Barros, Biologist 5511 3069-7686 silksbarr@ig.com.br
Contact: Decio Mion Junior, MD 5511 3069-7686 deciomion@uol.com.br

Locations
Brazil
General Hospital of School of Medicine - Universiy of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Silvana Barros, Biologist    5511 3069-7686    silksbarr@ig.com.br   
Contact: Decio Mion Junior, MD    5511 3069-7686    deciomion@uol.com.br   
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

No publications provided

Responsible Party: Decio Mion Junior, General Hospital Of School of Medicine - University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01390727     History of Changes
Other Study ID Numbers: FAPESP 2010/06921-2
Study First Received: May 23, 2011
Last Updated: July 8, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Fundação de Amparo à Pesquisa do Estado de São Paulo:
hypertension
device-guided breathing
autonomic function

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014