Effects of Slow Breathing on Blood Pressure and Autonomic Function

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Other: Listen music; Device: Device-guided breathing (Resperate - InterCure, Israel)

• Registration Number: NCT01390727
• Lead Sponsor: Fundação de Amparo à Pesquisa do Estado de São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-06
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Listen music	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
Device-guided breathing	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

Primary Outcome Measures

Name	Time	Method
blood pressure reduction	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

Name	Time	Method
autonomic regulation	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).

Trial Locations

Locations (1)

General Hospital of School of Medicine - Universiy of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil