NCT01390727

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started May 2011

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

May 23, 2011

Last Update Submit

May 6, 2016

Conditions

Hypertension

Keywords

hypertensiondevice-guided breathingautonomic functionResperate

Outcome Measures

Primary Outcomes (1)

  • blood pressure reduction

    The blood pressure reduction in mmHg will be verified by office blood pressure measurement and ambulatory blood pressure monitoring (ABPM)

    8 weeks after the randomization

Secondary Outcomes (1)

  • autonomic regulation

    8 weeks after randomization

Study Arms (2)

Listen music

PLACEBO COMPARATOR

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

Other: Listen music

Device-guided breathing

ACTIVE COMPARATOR

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

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

Interventions

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

Device-guided breathing
Listen musicOTHER

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

Listen music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of School of Medicine - Universiy of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • de Barros S, da Silva GV, de Gusmao JL, de Araujo TG, de Souza DR, Cardoso CG Jr, Oneda B, Mion D Jr. Effects of long term device-guided slow breathing on sympathetic nervous activity in hypertensive patients: a randomized open-label clinical trial. Blood Press. 2017 Dec;26(6):359-365. doi: 10.1080/08037051.2017.1357109. Epub 2017 Jul 20.

    PMID: 28724309DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Decio Mion Junior, MD

    General Hospital of School of Medicine - University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Phd

Study Record Dates

First Submitted

May 23, 2011

First Posted

July 11, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 9, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)