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

NCT ID: NCT03216317

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-15

Study Completion Date

2018-07-30

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Subjects will perform three weekly sessions of isometric handgrip training consisting of four series (two in each arm) with two minutes of isometric contraction with intensity of 30% of maximum voluntary contraction with interval between the two-minute series under the guidance of the trained researcher.

Group Type ACTIVE_COMPARATOR

Intervention Group

Intervention Type BEHAVIORAL

Isometric handgrip training consisting of four series

Control Group

Individuals randomized to Control Group will be encouraged to increase their level of general physical activity, but without specific recommendations on physical activity.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention Group

Isometric handgrip training consisting of four series

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael MR Dias, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

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Unidade Básica de Saúde

Petrolina, Pernambuco, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 24582191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26467494 (View on PubMed)

Palmeira AC, Farah BQ, Silva GOD, Moreira SR, Barros MVG, Correia MA, Cucato GG, Ritti-Dias RM. Effects of isometric handgrip training on blood pressure among hypertensive patients seen within public primary healthcare: a randomized controlled trial. Sao Paulo Med J. 2021 Nov 15;139(6):648-656. doi: 10.1590/1516-3180.2020.0796.R1.22042021. eCollection 2021.

Reference Type DERIVED
PMID: 34787298 (View on PubMed)

Other Identifiers

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55555

Identifier Type: -

Identifier Source: org_study_id

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