Breathing Exercises of CardioBreath Application on Autonomic and Vascular Function in Hypertension

NCT06917729 | Not Yet Recruiting

• 2 other identifiers: 6131/247.323.318
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

Hypertension is one of the greatest public health challenges, affecting more than one billion people worldwide and representing a significant financial and public health burden. It is responsible for a high number of cardiovascular events, such as heart attacks and strokes. Although pharmacological treatment is effective, non-pharmacological interventions are essential for the sustainable management of blood pressure, especially in its early stages. Respiratory exercises have shown potential in reducing blood pressure and improving cardiac vagal modulation, promoting cardiovascular health benefits. This study aims to evaluate the effectiveness of guided respiratory exercises using the CardioBreath app in improving vagal modulation and reducing arterial stiffness in adults with prehypertension or hypertension over six weeks. This is a randomized clinical trial involving adults with prehypertension or hypertension, divided into intervention and control groups. The intervention group will use CardioBreath to perform daily breathing exercises, with weekly remote monitoring. Assessments will include heart rate variability parameters, baroreflex sensitivity, pulse wave velocity, and quality of life. It is expected that the use of the app will significantly improve vagal modulation and arterial stiffness, demonstrating the potential of this intervention for the non-pharmacological management of hypertension. The use of CardioBreath may offer an accessible and effective alternative for blood pressure control, with the potential to be integrated into public health programs focused on low-cost, highly accessible interventions for the prevention and management of hypertension.

Conditions

Hypertension; Pre Hypertension

Keywords

Hypertension; Breathing Exercises; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Cardiac Vagal Modulation

  Cardiac vagal modulation obtained by the heart rate variability (HRV) in frequency domain conducted in the Finometer System, with a finger installed in the middle finger of the right hand of the patient, with a continuous peripheric blood pressure signal, collected with the subjects in rest position, in a room with light and temperature controlled. Baseline data is collected for ten minutes immediatly after the Finometer calibration.Following this, the subject will undergo slow breath exercise throught the CardoBreath application for five minutes, and afterward a new sequency of ten minutes of data collection. The signals are ransformed from a analogic-to-digital sequency, and analysed by Cardiseries software. Vagal modulation will be considered the high frequency (HF) band of the frequency domain analysis, between 0,15 to 0,4 Hz.

  At baseline and after six weeks

Secondary Outcomes (1)

• Pulse wave velocity

  At baseline and after six weeks

Study Arms (2)

CardioBreath Application

ACTIVE COMPARATOR

Lessons in the CardioBreath app are based on the breathing techniqueUjjayi Pranayama(Victorious breathing), which uses the narrowing of the glottis through a soft noise in the throat to prolong the two phases of breathing. The sessions used for the intervention will be the Prescription, based on data from the users' profile, including the Spontaneous Respiratory Rate (SRR) as the basis for prescribing the exercises, the relaxation section, which aims to deeply relax the respiratory muscles and others, and the Victorious section, where the user achieves mastery over his/her breathing.

Other: CardioBreath

Control

SHAM COMPARATOR

Participants will receive graphic material based on the contents of cardioBreath Application, with instructions to be aware of their breath , control it towards lower rates by increasing respiratory phases through ujjayi pranayama

Other: CardioBreath

Interventions

CardioBreath OTHER

Twice a day for ten minutes,5 days during the week CardioBreath app will be based on Prescription section , using breathing technique Ujjayi Pranayama, based on spontaneous respiratory rate of users, gamified to induce the user to improve performance of the exercises reducing the exercises respiratory exercises

Also known as: CardioBreath Application

CardioBreath Application; Control

Eligibility Criteria

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

You may qualify if:

• BP\>130mmHg X 80mmHg or previous medical diagnosis of pre- hypertension or hypertension

You may not qualify if:

• use of beta-blockers
• drugs that depress the central nervous system
• clinical conditions that prevent participation after evaluation by the team
• individuals without a cell phone or tablet (which would make the proposed study unfeasible

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (2)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

Instituto de Cardiologia do RioGrande do Sul

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Cláudia Fetter, Ph.D.

CONTACT

+ 55 51 984516888; profclaudiafetter@gmail.com

Study Design

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

Model Details: Participants will be randomized (1:1) to intervention via the website www.randomization.com :Group 1-Group with intervention and Group 2-Non- intervention group (control). After randomization, participants will be instructed on how their group's intervention will work, and will also receive the instruments and equipment to carry out the intervention, at no personal cost. The sessions used will be the Prescription, based on data from the users' profile, including the Spontaneous Respiratory Rate (SRR) as the basis for prescribing the exercises, the relaxation section, and the Victorious section, where the user achieves mastery over his/her breathing. The same will be installed free of charge on the participant's cell phone . In group 2 (without intervention), participants will receive teaching material based on the lessons from the CardioBreath and after the time of intervention they will receive freely the Cardiobreath application.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)