Isometric Training on Blood Pressure and on the Autonomic Modulation of Hypertensive Patients

Hypertension Clinical Trial

Official title:

Effect of Handgrip's Isometric Training on Blood Pressure and on the Autonomic Modulation of Hypertense Individuals at the Basic Health Units: A Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216317
• Other study ID #: 55555
• Status: Completed
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: July 2017
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: analyze the effects of isometric handgrip exercise on arterial pressure and on the autonomic cardiac modulation of hypertensive individuals treated in the Unified Health System (UHS).

Intervention: Patients were randomized into Supervised group (SG) and control group (CG). SG will perform supervised isometric handgrip exercise for three weekly sessions in four sets with two minutes of isometric contraction with 30% of maximal voluntary contraction (MVC), In CG, individuals will be encouraged to increase their level of physical activity.

Measurements: Blood pressure, autonomic modulation

Description:

The objective of this study is to analyze the effects of isometric handgrip exercise on arterial pressure and on the autonomic cardiac modulation of hypertensive individuals treated in the Unified Health System (UHS). Two prospective, randomized, controlled trials will be conducted with hypertensive patients in the public health network of Petrolina (PE) and São Paulo (SP). Included in the study will be individuals with an age group over 18 years of both genders, with systemic arterial hypertension (SAH) controlled with the use of antihypertensive medication, non-smokers and without the presence of diabetes or other cardiovascular diseases that will be allocated randomly in two groups: supervised group (SG) and control group (CG). SG will be instructed to perform supervised isometric handgrip exercise for three weekly sessions in four sets with two minutes of isometric contraction with 30% of maximal voluntary contraction (MVC) of the subjects and interval between two-minute series. In CG, individuals will be encouraged to increase their level of physical activity. Prior to initiation and after 12 weeks of intervention, blood pressure, autonomic cardiac modulation and level of physical activity will be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• It will include individuals with age range over 18 years of both genders and with controlled hypertension using antihypertensive medication and without the presence of diabetes or other cardiovascular diseases and who do not present high cardiovascular risk.

Exclusion Criteria:

• Those individuals who: a) are diagnosed of diseases such as dyslipidemia, diabetes mellitus, cardiovascular or pulmonary diseases; B) adhere to another program of physical activities besides the training offered by the present study; C) change the class and dose of medication during the study; and d) aggravate the disease.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Intervention Group
Isometric handgrip training consisting of four series

Locations

Country	Name	City	State
Brazil	Unidade Básica de Saúde	Petrolina	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Carlson DJ, Dieberg G, Hess NC, Millar PJ, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis. Mayo Clin Proc. 2014 Mar;89(3):327-34. doi: 10.1016/j.mayocp.2013.10.030. Review. — View Citation

Inder JD, Carlson DJ, Dieberg G, McFarlane JR, Hess NC, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis to optimize benefit. Hypertens Res. 2016 Feb;39(2):88-94. doi: 10.1038/hr.2015.111. Epub 2015 Oct 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure measure	The subjects will remain for ten minutes in the seated position, following the guidelines of the VII Brazilian Direction of Hypertension. Three consecutive measurements, one minute apart, in the non-dominant arm and with a cuff size suitable for the circumference of the arm will be performed. The value used will be the average of the last two measures, as recommended by the VII Brazilian Arterial Hypertension Guideline.	12 weeks
Secondary	Heart rate variability measure	The patients will remain 10 minutes lying down, during which the heart rate variability (HRV) intervals will be registered, using a valid heart rate monitor for this function (RS800CX, Polar Electro, Finland). It will be considered a valid signal those with at least five minutes of signal stationary.	12 weeks