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

NCT03182205 | Completed

• 1 other identifier: CAAE64969617000005133
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehypertension; Hypertension

Keywords

Breathing Exercises; Autonomic Nervous System; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Autonomic nervous system

  Baseline, 60 minutes and 24 hours post each intervention

• Peripheral blood flow

  Baseline and 60 minutes post each intervention

Study Arms (2)

Inspiratory muscle exercise (IME)

EXPERIMENTAL

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

Other: IME

Sham IME

SHAM COMPARATOR

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

Interventions

IME OTHER

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.

Also known as: Inspiratory muscle exercise

Inspiratory muscle exercise (IME)

Sham IME OTHER

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.

Also known as: Sham inspiratory muscle exercise

Sham IME

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiovascular or respiratory diseases
• Arrhythmias detected during electrocardiographic monitoring
• Inability to perform the proposed protocol

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

Hospital Universitário da UFJF

Juiz de Fora, Minas Gerais, 36038330, Brazil

Location

Related Publications (7)

• 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.

  PMID: 23970114 BACKGROUND

• 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.

  PMID: 21985749 BACKGROUND

• 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.

  PMID: 23385649 BACKGROUND

• 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.

  PMID: 20142783 BACKGROUND

• 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.

  PMID: 25653080 BACKGROUND

• 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.

  PMID: 23812534 BACKGROUND

• 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.

  PMID: 25395284 BACKGROUND

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lilian P Silva

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 9, 2017
• Study Start: June 26, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)