Sympathetic and Blood Pressure Responses to Aerobic Exercise and Guided Respiration in Hypertensives

NCT ID: NCT02608827

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-12-31

Brief Summary

Hypertension is serious health problem in Brazil and affects almost 30%of adult population. It is known that there are pharmacologic and nonpharmacologic strategies for treating hypertension. Aerobic exercise and slow breathing are nonpharmacologic methods that reduce blood pressure in an isolated form, but its combinations has never been studied. The aim of this study is to evaluate the association of both strategies and also the mechanisms involved in blood pressure reduction using slow breathing, in stages 1 and 2 hypertensives.

Detailed Description

The combination of drugs and no medication for hypertension treatment has been widely recommended, with emphasis on aerobic exercises (EXE), relaxation exercises, and the use of equipment designed to decrease the respiratory rate called Resperate®. This intervention has demonstrated a hypotensive effect in pressure measurements in clinical blood pressure and ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM). It is unknown; however, if slow breathing (GRL) associated with other intervention, such as EXE, for example, may potentiate the blood pressure (BP) reduction. The aim of this study will be evaluate the acute responses of muscle sympathetic nerve activity (MSNA) and BP, in association of the slow breathing versus control (listening to calm music) and the 24 hour blood pressure response after the association of EXE and GRL. Twenty hypertensives will be evaluated between 18 to 60 years old, mens and woman, sedentary, non-obese, without target organs damage and associated comorbidities, after 4 weeks of placebo use (washout period). Participants will be randomly divided into 2 groups (GRL and GC) and both perform EXE on a cycle ergometer. Volunteers will make a ABPM before and after the experimental session. In this session will be recorded for 10 minutes, prior to the physical exercise, the systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR) and heart rate (HR), after that, It will be held microneurography to register also the MSNA for 10 minutes, then they will perform either GRL or listened to music for 15 minutes. Variables will be measures for more 10 minutes. After finishing the session, volunteers will put the ABPM and will go away.

Conditions

Hypertension

Keywords

Hypertension; slow breathing; sympathetic nerve activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slow breathing group (GRL)

After randomization and have done aerobic exercise, patients allocated in this arm of the study, using the device-guided breathing - Slow breathing group (GRL), for 15 minutes during the experimental session.

Group Type: ACTIVE_COMPARATOR

Resperate®-InterCure Ltda

Intervention Type: DEVICE

The device-guided breathing - Resperate®-InterCure Ltda, uses sound to guide and therefore reduce the respiration rate in individuals.

Music group (GC)

After randomization and have done aerobic exercise, patients allocated in this study arm will hear slow music - Music group (GC), for 15 minutes during the experimental session.

Group Type: PLACEBO_COMPARATOR

Music group (GC)

Intervention Type: OTHER

The patients in this arm will hear slow music - Music group (GC).

Interventions

Resperate®-InterCure Ltda

The device-guided breathing - Resperate®-InterCure Ltda, uses sound to guide and therefore reduce the respiration rate in individuals.

Intervention Type: DEVICE

Music group (GC)

The patients in this arm will hear slow music - Music group (GC).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 to 60 years, of both sexes not obese (BMI <30 kg / m2);
• Sedentary not to perform physical exercise for at least three months;
• Hypertensive without target organ damage or untreated stage I and stage II (SBP 140-179 mmHg and DBP 90-109 mmHg) after four weeks with the use of placebo and without comorbidities; What would agree to participate in the study by signing the Instrument of Consent;

Exclusion Criteria

• Patients who presented blood pressure greater than 180/100 mmHg at any rate during the home monitoring of blood pressure and they needed treatment with active drug;
• White-coat hypertension, or persistently elevated BP measurements (≥ 140/90 mmHg) in the office and BP means be considered normal in HBPM or ABPM.
• Masked Hypertension, or high blood pressure office <140/90 mmHg, and 24-hour ABPM with daytime BP> 130/85 mmHg;
• Patients with a history of alcoholism, drug abuse or mental disorders that could invalidate the consent, or limit the patient's ability to comply with the rules of the Protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tatiana Goveia de Araújo

Post graduate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FAPESP 2010/11413-6

Identifier Type: -

Identifier Source: org_study_id