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

February 7, 2019 updated by: Hospital Israelita Albert Einstein

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

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
      • Petrolina, Pernambuco, Brazil
        • Unidade Básica de Saúde

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:

  • 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.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Intervention Group
Isometric handgrip training consisting of four series
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability measure
Time Frame: 12 weeks
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

Collaborators and Investigators

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

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Raphael MR Dias, PhD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 15, 2017

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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