Effects of Slow Breathing on Blood Pressure and Autonomic Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Listen music

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Device-guided breathing (Resperate - InterCure, Israel)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No