Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

NCT ID: NCT02348138

Last Updated: 2017-10-04

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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The main purpose this study is to analyze the effects of isometric handgrip training on cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under anti-hypertensive medication, will be selected and randomly distributed into three groups: home-based isometric handgrip training (HBT), supervised isometric handgrip training (ST) and control group (CG).Subjects assigned to the HBT and ST will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction. However, the subjects of the HBT group conduct the training without daily supervision. Subjects randomized to the CG will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations.Baseline and after 12 weeks of intervention, the following cardiovascular risk indicators will be obtained: blood pressure, arterial stiffness, cardiac autonomic modulation, vasodilatory capacity and oxidative and inflammatory stress markers, in addition to microalbuminuria. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. If the premises of this test are met. The level of significance that will be adopted is p\<0.05.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Home-based isometric handgrip training

All participants that will be assigned to home-based isometric handgrip training (HBT) will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction; however, the training will be performed without daily supervision. Therefore, the subjects will receive a logbook to record the exercise sessions. In addition, visits will be scheduled at weeks 1, 3, 6, 9 and 11 to provide feedback to individuals and discuss potential problems in conducting training.

Group Type EXPERIMENTAL

Isometric handgrip training

Intervention Type OTHER

The two experimental groups (HBT and ST) will receive intervention with isometric handgrip exercise for 12 weeks, and the HBT group without daily supervision.

Supervised isometric handgrip training

All participants that will be assigned to supervised isometric handgrip training (ST) will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction with. The training will be performed with daily supervision.

Group Type EXPERIMENTAL

Isometric handgrip training

Intervention Type OTHER

The two experimental groups (HBT and ST) will receive intervention with isometric handgrip exercise for 12 weeks, and the HBT group without daily supervision.

Control group

Subjects randomized to the control group (CG) will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Isometric handgrip training

The two experimental groups (HBT and ST) will receive intervention with isometric handgrip exercise for 12 weeks, and the HBT group without daily supervision.

Intervention Type OTHER

Other Intervention Names

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Exercise

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of hypertension;
* Must be under anti-hypertensive medications of three months or more;
* May not present diabetes or other cardiovascular diseases;
* May not engaged in regular physical activity;
* May not have disabilities that compromise the physical activity practices.

Exclusion Criteria

* Not perform more than 85% of the training sessions;
* Present diagnosis of metabolic diseases, cardiovascular or pulmonary during the study;
* Adherence to other physical activity program beyond the training offered by this study;
* Change in class and / or dose of medication during the study;
* Not using the medication regularly;
* Worsening of the disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Ciência e Tecnologia de Pernambuco

OTHER

Sponsor Role collaborator

University of Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Breno Quintella Farah

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raphael M Ritti-Dias, Doctor

Role: STUDY_DIRECTOR

University of Pernambuco

Breno Q Farah, Phd student

Role: PRINCIPAL_INVESTIGATOR

University of Pernambuco

Locations

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University of Pernambuco

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ISOPRESS

Identifier Type: -

Identifier Source: org_study_id