Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals

Study Overview
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Brief Summary
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This study aims to evaluate the autonomic and hemodynamic responses triggered by inspiratory muscle exercise in prehypertensive and hypertensive individuals. The reason that leads us to this study refers to clinical relevance for individuals with high blood pressure levels, since this type of exercise can act as a important nonpharmacological agent for arterial pressure control. In addition, this study aims to elucidate the mechanisms involved in cardiovascular responses to inspiratory muscle exercise and, consequently, provide safety in the prescription of these for this population.

Detailed Description
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This is a randomized clinical trial, consisting of a convenience sample of patients from the Cardiology Department of the University Hospital (UH) of the Federal University of Juiz de Fora (FUJF). The patients will be invited to participate in the study and will receive information regarding the objectives and procedures of the study. In case of agreement with their inclusion in the study, they will sign a free and informed consent form. The entire experiment will be carried out in the Physical Evaluation Laboratory of the UH-FUJF, by the researchers previously trained in the application of the protocol. The stages of the experimental protocol will be divided into three days as described below. 1st day of the experimental protocol (initial evaluation): medical historical, anthropometric evaluation, electrocardiographic monitoring at rest, evaluation of respiratory muscle strength and familiarization with the muscle training device. All volunteers will be instructed to refrain from taking caffeinated and alcoholic beverages for 24 h before the evaluation and to have a good night's sleep. 2nd and 3rd days of the experimental protocol: all volunteers will be randomly assigned to two exercise sessions (ES): Sham IME (no load) and moderate intensity IME (40% of MIP). Initially, the volunteers will perform a 10-minute supine rest for heartbeat collection and subsequent calculation of heart rate variability (HRV), blood pressure and forearm blood flow measurements and evaluation of the baroreflex system. In sequence the ES will be conducted with continuous monitoring of blood pressure, heart rate and subjective perception of effort through the Borg Scale. Immediately and until one hour after the ES, it will be measured forearm blood flow, blood pressure, heart rate and evaluated the baroreflex system and HRV in order to investigate the acute effect of ES. The volunteers will be monitored using an equipment capable of evaluating the outpatient measurement of blood pressure and electrocardiogram for 24 hours in order to investigate the chronic effect of ES.

Official Title
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Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals: a Randomized Clinical Trial

Conditions
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Prehypertension, Hypertension

Intervention / Treatment
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* Other: IME
* Other: Sham IME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of prehypertension (systolic blood pressure > 121-139 mmHg / diastolic blood pressure > 81-89 mmHg) and stage 1 hypertension (systolic blood pressure > 140-159 mmHg / diastolic blood pressure > 90-99 mmHg) with low to moderate cardiovascular risk Do not use drugs to control blood pressure levels Sedentary for at least 6 months Exclusion Criteria: Cardiovascular or respiratory diseases Arrhythmias detected during electrocardiographic monitoring Inability to perform the proposed protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle exercise (IME)<br>Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 40% of maximal inspiratory pressure. | Other: IME<br>* The IME session protocol will consist of 8 sets of 2 minutes with 1 minute rest between sets. Inspiratory load will be set at 40% of maximum static inspiratory pressure. In addition, the volunteer will be instructed to perform diaphragmatic breathing, maintaining a respiratory rate in the range of 12 to 15 ipm (feedback from the evaluator) and the entire exercise protocol will be performed with the patient sitting with their feet flat on the floor and using a clip nasal.<br>* Other names: Inspiratory muscle exercise;|
| Sham Comparator: Sham IME<br>Participants will be submitted to inspiratory muscle exercise with the same equipment as the intervention group, but without a load generating resistance. | Other: Sham IME<br>* The Sham IME session protocol will consist of 8 sets of 2 minutes with 1 minute rest between sets, but without a load generating resistance. In addition, the volunteer will be instructed to perform diaphragmatic breathing, maintaining a respiratory rate in the range of 12 to 15 ipm (feedback from the evaluator) and the entire exercise protocol will be performed with the patient sitting with their feet flat on the floor and using a nasal clip.<br>* Other names: Sham inspiratory muscle exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline blood pressure levels in 24 hours | Noninvasive hemodynamic monitoring and ambulatory blood pressure monitoring | Baseline, 60 minutes and 24 hours post each intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic nervous system | Heart rate variability | Baseline, 60 minutes and 24 hours post each intervention | 
| Peripheral blood flow | Plethysmography of venous occlusion | Baseline and 60 minutes post each intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathing Exercises, Autonomic Nervous System, Hemodynamics