Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-09 @ 3:53 AM
Study NCT ID:
NCT03182205
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2017-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals
Sponsor:
Federal University of Juiz de Fora
Organization:
Study Overview
Official Title:
Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals: a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
1. 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.
2. 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.
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.
1. 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.
2. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: