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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182205
• Other study ID #: CAAE64969617000005133
• Status: Completed
• Phase: N/A
• First received: May 29, 2017
• Last updated: February 19, 2018
• Start date: June 26, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2018
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

Other:
• IME
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.
• Sham IME
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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário da UFJF	Juiz de Fora	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Archiza B, Simões 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. — View 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. — View 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. — View 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. — View Citation

Ramos PS, Da Costa Da Silva B, Gomes Da Silva LO, Araújo 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. — View 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. — View Citation

Souza H, Rocha T, Pessoa M, Rattes C, Brandão 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Autonomic nervous system	Heart rate variability	Baseline, 60 minutes and 24 hours post each intervention
Secondary	Peripheral blood flow	Plethysmography of venous occlusion	Baseline and 60 minutes post each intervention