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

NCT02608827 | Completed DMC

• 1 other identifier: FAPESP 2010/11413-6
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Hypertension; slow breathing; sympathetic nerve activity

Outcome Measures

Primary Outcomes (1)

• Blood pressure reduction

  The reduction in blood pressure in mmHg immediately after after a single session of the association of aerobic exercise and guided slow breathing and during 24 hours blood pressure monitoring (ABPM).

  A session (1 day), after the placebo period of 30 days.

Secondary Outcomes (1)

• Autonomic regulation

  A session (1 day), after the placebo period of 30 days.

Study Arms (2)

Slow breathing group (GRL)

ACTIVE COMPARATOR

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.

Device: Resperate®-InterCure Ltda

Music group (GC)

PLACEBO COMPARATOR

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.

Other: Music group (GC)

Interventions

Resperate®-InterCure Ltda DEVICE

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

Slow breathing group (GRL)

Music group (GC) OTHER

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

Music group (GC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Hypertension; Hypoventilation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: November 20, 2015
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2015
• Last Updated: October 27, 2016

Record last verified: 2016-10