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Clinical Trials/NCT03216317
NCT03216317
Completed
Not Applicable

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

Hospital Israelita Albert Einstein1 site in 1 country65 target enrollmentStarted: July 15, 2017Last updated:
ConditionsHypertension

Overview

Phase
Not Applicable
Status
Completed
Enrollment
65
Locations
1
Primary Endpoint
Blood Pressure measure

Overview

Brief 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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Blood Pressure measure

Time Frame: 12 weeks

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.

Secondary Outcomes

  • Heart rate variability measure(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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