Effects of Slow Breathing on Blood Pressure and Autonomic Function
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Device-guided breathing (Resperate - InterCure, Israel)
Listen music
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, device-guided breathing, autonomic function, Resperate
Eligibility Criteria
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
Sites / Locations
- General Hospital of School of Medicine - Universiy of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Listen music
Device-guided breathing
Arm 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
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
Outcomes
Primary Outcome Measures
blood pressure reduction
The blood pressure reduction in mmHg will be verified by office blood pressure measurement and ambulatory blood pressure monitoring (ABPM)
Secondary Outcome Measures
autonomic regulation
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).
Full Information
NCT ID
NCT01390727
First Posted
May 23, 2011
Last Updated
May 6, 2016
Sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01390727
Brief Title
Effects of Slow Breathing on Blood Pressure and Autonomic Function
Official Title
Effects of Slow Breathing on Blood Pressure and Autonomic Function in Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, device-guided breathing, autonomic function, Resperate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Listen music
Arm Type
Placebo Comparator
Arm 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
Arm Title
Device-guided breathing
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Device-guided breathing (Resperate - InterCure, Israel)
Intervention 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
Intervention Type
Other
Intervention Name(s)
Listen music
Intervention 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
Primary Outcome Measure Information:
Title
blood pressure reduction
Description
The blood pressure reduction in mmHg will be verified by office blood pressure measurement and ambulatory blood pressure monitoring (ABPM)
Time Frame
8 weeks after the randomization
Secondary Outcome Measure Information:
Title
autonomic regulation
Description
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).
Time Frame
8 weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Decio Mion Junior, MD
Organizational Affiliation
General Hospital of School of Medicine - University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of School of Medicine - Universiy of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28724309
Citation
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.
Results Reference
derived
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Effects of Slow Breathing on Blood Pressure and Autonomic Function
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