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NCT Number: NCT01390727

Effects of Slow Breathing on Blood Pressure and Autonomic Function

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of School of Medicine - Universiy of Sao Paulo

São Paulo, 05403-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device-guided breathing (Resperate - InterCure, Israel)

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

listen music

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

Primary outcomes

  1. blood pressure reduction

    Time frame: 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 outcomes

  1. autonomic regulation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2011
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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