Effects of Slow Breathing on Blood Pressure and Autonomic Function

Fundação de Amparo à Pesquisa do Estado de São Paulo

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Device: Device-guided breathing (Resperate - InterCure, Israel); Other: Listen music

Study type: Interventional

Funder types: Other

Identifiers

NCT01390727

FAPESP 2010/06921-2

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups, including a placebo group

Listen music

Placebo Comparator group

Description:

After randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks

Treatment:

Other: Listen music

Device-guided breathing

Active Comparator group

Description:

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

Treatment:

Device: Device-guided breathing (Resperate - InterCure, Israel)