Effects of Slow Breathing on Blood Pressure and Autonomic Function

Hypertension Clinical Trial

Official title:

Effects of Slow Breathing on Blood Pressure and Autonomic Function in Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390727
• Other study ID #: FAPESP 2010/06921-2
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2011
• Last updated: May 6, 2016
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2016
• Source: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

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

Locations

Country	Name	City	State
Brazil	General Hospital of School of Medicine - Universiy of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure reduction	The blood pressure reduction in mmHg will be verified by office blood pressure measurement and ambulatory blood pressure monitoring (ABPM)	8 weeks after the randomization	Yes
Secondary	autonomic regulation	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).	8 weeks after randomization	Yes