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

Primary Purpose

Prehypertension, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
IME
Sham IME
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring Breathing Exercises, Autonomic Nervous System, Hemodynamics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitário da UFJF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory muscle exercise (IME)

Sham IME

Arm Description

Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 40% of maximal inspiratory pressure.

Participants will be submitted to inspiratory muscle exercise with the same equipment as the intervention group, but without a load generating resistance.

Outcomes

Primary Outcome Measures

Change from baseline blood pressure levels in 24 hours
Noninvasive hemodynamic monitoring and ambulatory blood pressure monitoring

Secondary Outcome Measures

Autonomic nervous system
Heart rate variability
Peripheral blood flow
Plethysmography of venous occlusion

Full Information

First Posted
May 29, 2017
Last Updated
February 19, 2018
Sponsor
Federal University of Juiz de Fora
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1. Study Identification

Unique Protocol Identification Number
NCT03182205
Brief Title
Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals
Official Title
Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Hypertension
Keywords
Breathing Exercises, Autonomic Nervous System, Hemodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle exercise (IME)
Arm Type
Experimental
Arm Description
Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 40% of maximal inspiratory pressure.
Arm Title
Sham IME
Arm Type
Sham Comparator
Arm Description
Participants will be submitted to inspiratory muscle exercise with the same equipment as the intervention group, but without a load generating resistance.
Intervention Type
Other
Intervention Name(s)
IME
Other Intervention Name(s)
Inspiratory muscle exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham IME
Other Intervention Name(s)
Sham inspiratory muscle exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline blood pressure levels in 24 hours
Description
Noninvasive hemodynamic monitoring and ambulatory blood pressure monitoring
Time Frame
Baseline, 60 minutes and 24 hours post each intervention
Secondary Outcome Measure Information:
Title
Autonomic nervous system
Description
Heart rate variability
Time Frame
Baseline, 60 minutes and 24 hours post each intervention
Title
Peripheral blood flow
Description
Plethysmography of venous occlusion
Time Frame
Baseline and 60 minutes post each intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilian P Silva
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário da UFJF
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36038330
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23970114
Citation
Archiza B, Simoes RP, Mendes RG, Fregonezi GA, Catai AM, Borghi-Silva A. Acute effects of different inspiratory resistive loading on heart rate variability in healthy elderly patients. Braz J Phys Ther. 2013 Jul-Aug;17(4):401-8. doi: 10.1590/S1413-35552012005000100. Epub 2013 Aug 23.
Results Reference
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PubMed Identifier
21985749
Citation
Ferreira JB, Plentz RD, Stein C, Casali KR, Arena R, Lago PD. Inspiratory muscle training reduces blood pressure and sympathetic activity in hypertensive patients: a randomized controlled trial. Int J Cardiol. 2013 Jun 5;166(1):61-7. doi: 10.1016/j.ijcard.2011.09.069. Epub 2011 Oct 9.
Results Reference
background
PubMed Identifier
23385649
Citation
Hering D, Kucharska W, Kara T, Somers VK, Parati G, Narkiewicz K. Effects of acute and long-term slow breathing exercise on muscle sympathetic nerve activity in untreated male patients with hypertension. J Hypertens. 2013 Apr;31(4):739-46. doi: 10.1097/HJH.0b013e32835eb2cf.
Results Reference
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PubMed Identifier
20142783
Citation
McConnell AK, Griffiths LA. Acute cardiorespiratory responses to inspiratory pressure threshold loading. Med Sci Sports Exerc. 2010 Sep;42(9):1696-703. doi: 10.1249/MSS.0b013e3181d435cf.
Results Reference
background
PubMed Identifier
25653080
Citation
Ramos PS, Da Costa Da Silva B, Gomes Da Silva LO, Araujo CG. Acute hemodynamic and electrocardiographic responses to a session of inspiratory muscle training in cardiopulmonary rehabilitation. Eur J Phys Rehabil Med. 2015 Dec;51(6):773-9. Epub 2015 Feb 5.
Results Reference
background
PubMed Identifier
23812534
Citation
Rodrigues F, Araujo AA, Mostarda CT, Ferreira J, de Barros Silva MC, Nascimento AM, Lira FS, De Angelis K, Irigoyen MC, Rodrigues B. Autonomic changes in young smokers: acute effects of inspiratory exercise. Clin Auton Res. 2013 Aug;23(4):201-7. doi: 10.1007/s10286-013-0202-1. Epub 2013 Jun 28.
Results Reference
background
PubMed Identifier
25395284
Citation
Souza H, Rocha T, Pessoa M, Rattes C, Brandao D, Fregonezi G, Campos S, Aliverti A, Dornelas A. Effects of inspiratory muscle training in elderly women on respiratory muscle strength, diaphragm thickness and mobility. J Gerontol A Biol Sci Med Sci. 2014 Dec;69(12):1545-53. doi: 10.1093/gerona/glu182.
Results Reference
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Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals

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