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

Condition(s) studied

Investigational drug(s) / intervention(s)

CardioBreath: 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

Study 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.

Eligibility

Primary outcome measure(s)

• Cardiac Vagal Modulation — At baseline and after six weeks
  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.

Trial sites (2)

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