Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.

Study Overview
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Brief Summary
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The purpose of this study is to determine inspiratory muscle training effects on blood pressure, functional capacity and quality of life in hypertensive patients.

Detailed Description
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The interaction between respiratory function and cardiovascular system, as well as the present alterations in these systems, due to diseases such as Hypertension, diabetes and chronic heart failure, are the factors that potentially participate of the pathogenic frame in these situations. Consequently, it is so related to reduction of functional capacity, endothelial dysfunction of the sympathetic and parasympathetic cardiovascular control and morphologic alterations on the skeletal muscles, including ventilatory muscles. On the other hand, a proinflammatory state also participates of this dysfunction and reduced function capacity situation. Cardiovascular risk factors, such as hypertension, increased heart rate variability, diabetes and heart failure explain the occurrence of the majority of cardiovascular events in the entire world and so in Brazil. Studies with experimental models and in patients with cardiovascular diseases identified important inflammatory activity associated to risk factors and preceding clinical events. Inspiratory muscle training (IMT) shows consistent results in the improvement of functional capacity in athletes, sedentary subjects, heart failure patients and in animals submitted to an IMT model. The study of alterations in cardiorespiratory interaction, functional capacity and cardiovascular control mechanisms (sympathetic, parasympathetic by heart rate variability), altogether, in hypertension, is a single opportunity to identify new pathogenic mechanisms involved in the reduction of functional capacity as well as promote its quantification. Therefore, the effects of IMT on these alterations are still not well understood. In this way, the response to IMT is a complement to epidemiologic and clinical models, as potential source of new possibilities in the research field.

Official Title
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Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.

Conditions
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Reduction of Blood Pressure in Hypertensive Patients., Improvement of Cardiovascular Autonomic Control., Improvement of Functional Capacity., Improvement of Quality of Life.

Intervention / Treatment
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* Other: Inspiratory Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 25 and 70 Hypertension in all stages: 2.1. Prehypertension - Systolic blood pressure (SBP) of 120 to 139 and/or diastolic blood pressure (DBP) of 80 to 89 mmHg 2.2.Stage 1 Hypertension - SBP of 140 to 159 mmHg and/or DBP of 90 to 99 mmHg 2.3.Stage 2 Hypertension - SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg Exclusion Criteria: Disagreement with consent form Thoracic pain (angina) Hypertension instability Antihypertensive drugs alterations within 30 days before or during the study Diabetes Chronic pulmonary obstructive disease Incapability of executing the functional tests Asthma Chronic Heart Failure Obesity Cardiovascular diseases complications

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle Training<br>It will me performed a loaded training of ventilatory muscles in patients with Hypertension. Its is done with the practice of breathing exercises associated to an training device, specific for this kind of intervention. | Other: Inspiratory Muscle Training<br>* Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences on blood pressure levels | Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying. | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of Heart rate variability |  | eight weeks | 
| improvement of quality of life | To measure the quality of life, it is used the SF36 short form questionary. | eigth weeks | 
| Improvement of Functional Capacity | It is measure by the oxytgen consumption accessed by ergospirometry. | eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inspiratory Muscle Training, Hypertension, Breathing Exercises, Cardiac Rehabilitation