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临床试验/NCT06917729
NCT06917729尚未招募不适用

Responses on Arterial Stiffness and Cardiac Vagal Modulation to Breathing Exercises Through the Use of CardioBreath Application in Hypertension and Pre Hypertension; a Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
2
主要终点
Cardiac Vagal Modulation

研究概览

简要总结

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.

详细描述

Systemic Arterial Hypertension (SAH) affects 1.33 billion people globally, representing 10% of global health costs. In the US, a study published in 2019 estimated that annual spending due to hypertension was $56 billion. According to the Surveillance Survey of Risk and Protective Factors for Chronic Diseases by Telephone Survey (Vigitel), carried out in 2021 and with a report published in 2022, the frequency of adults (18 years or older) in Brazilian capitals who reported a medical diagnosis of hypertension was 26.3%. This represents an increase in relation to the data from 2011, when the percentage was 24.3%. Hypertension is the main risk factor for events such as Acute Myocardial Infarction (AMI) and Stroke (CVA). The mortality rate due to hypertension in Brazil reached the highest value in the last ten years, with 18.7 deaths per 100,000 inhabitants in 2021 .

The 2024 European Society of Cardiology (ESC) Guideline on the management of elevated blood pressure (BP) and hypertension presents significant changes from previous versions. The new title reflects the understanding of cardiovascular risk as a continuous spectrum, emphasizing the importance of accurate BP measurement, recommending the use of validated devices, standardized techniques, and out-of-office measurement.

Treatment strategies include lifestyle interventions and drug therapy, with an emphasis on lower BP targets and combination therapy from the outset, addressing the management of hypertension in specific populations, such as women, the elderly, patients with Chronic Kidney Disease (CKD) and Diabetes Mellitus (DM). Resistant and secondary hypertension are also discussed, with recommendations for diagnosis and treatment. Psychosocial aspects, such as communication of diagnosis and adherence to treatment, are highlighted. Self-care and BP monitoring are encouraged, with the caveat that evidence for digital tools is still limited, recommending the importance of a patient- centered approach and shared decision-making. Lifestyle change is considered an essential component in the management of high blood pressure and hypertension.

Within this context, the need to control blood pressure values is expressed in order to reduce risks and contain the progression of the pathology, the inclusion of non-pharmacological approaches becomes imperative. Referring to the genesis of hypertension, there is an imbalance in the Autonomic Nervous System (ANS), which presents a sustained increase in sympathetic neural activity and a reduction in vagal modulation, implying a reduction in

baroreflex sensitivity, the heart's beat-to-beat blood pressure regulatory mechanism, generating a sustained increase in blood pressure (BP) values and the establishment of hypertension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: CardioBreath (Other)

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

干预措施: CardioBreath (Other)

结局指标

主要结局

Cardiac Vagal Modulation

时间窗: 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.

次要结局

  • Pulse wave velocity(At baseline and after six weeks)

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Janaina Pinheiro

Nurse

Instituto de Cardiologia do Rio Grande do Sul

研究点 (2)

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