Effects of Slow Breathing on Blood Pressure and Autonomic Function

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Listen music; Device: Device-guided breathing (Resperate - InterCure, Israel)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • General Hospital of School of Medicine - Universiy of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• de Barros S, da Silva GV, de Gusmao JL, de Araujo TG, de Souza DR, Cardoso CG Jr, Oneda B, Mion D Jr. Effects of long term device-guided slow breathing on sympathetic nervous activity in hypertensive patients: a randomized open-label clinical trial. Blood Press. 2017 Dec;26(6):359-365. doi: 10.1080/08037051.2017.1357109. Epub 2017 Jul 20.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): May 9, 2016
• Last Update Submitted That Met QC Criteria: May 6, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: hypertension; autonomic function; device-guided breathing; Resperate
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypertension; Respiratory Aspiration; Hypoventilation
• Other Study ID Numbers: FAPESP 2010/06921-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No