Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

October 2, 2017 updated by: Breno Quintella Farah, University of Pernambuco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50100-130
        • University of Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: 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.
Other Names:
  • Exercise
EXPERIMENTAL: 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.
Other: 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.
Other Names:
  • Exercise
NO_INTERVENTION: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in office blood pressure
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ambulatory blood pressure
Time Frame: Basaline and 12 weeks
Basaline and 12 weeks
Change in central blood pressure
Time Frame: Basaline and 12 weeks
Basaline and 12 weeks
Change in cardiac autonomic modulation
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in vasodilatory capacity
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in arterial stiffness
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in markers of oxidative stress
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in markers of inflammation
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to training
Time Frame: 12 weeks
Adherence to training will be evaluated by the number of subjects who completed the two types of training
12 weeks
Change in handgrip strength
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pernambuco

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco
Conselho Nacional de Desenvolvimento Científico e Tecnólogico - CNPQ

Investigators

  • Principal Investigator: Breno Q Farah, Phd student, University of Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (ESTIMATE)

January 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISOPRESS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe