Effects of Slow Breathing on Blood Pressure and Autonomic Function

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01390727

Enrollment

Registered

2011-07-11

Start date

2011-05-31

Completion date

2014-12-31

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, device-guided breathing, autonomic function, Resperate

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.

Interventions

DEVICEDevice-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

OTHERListen 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026