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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstituto de Cardiologia do Rio Grande do Sul

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CardioBreath

    Other intervention

    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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: CardioBreath ApplicationActive comparator 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

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.

Time frame
At baseline and after six weeks

Secondary outcomes

1

Pulse wave velocity

Pulse wave velocity (PWV) is obtained by the oscilometric method, dividing the carotid- femoral distance by the travel time of the systolic wave. PWV will be measured by Arteris equipment in a seated position, at rest, in an environment with controlled temperature and lighting, with the cuff fitted to the left upper limb. Before the collection, the individual must empty their bladder and during the data collection, they must remain at rest for the measurement, in a quiet environment, with controlled temperature (± 23 ° C) and lighting. The device will perform 4 blood pressure measurements, the first measurement will be discarded and the other three will be analyzed by the MAPA's software to calculate the PWV.

Time frame
At baseline and after six weeks

Other outcomes

Sponsors and contacts

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