CClinicalTrials.gg
CompletedNCT03216317Updated Feb 8, 2019

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

An interventional study of Intervention Group in Hypertension, sponsored by Hospital Israelita Albert Einstein. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Hypertension
  • Hypotension
  • Cardiovascular system
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 65 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralIntervention Group

    Isometric handgrip training consisting of four series

06

What researchers measure

Primary outcomes

  1. Blood Pressure measure

    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.

    Time frame: 12 weeks

Secondary outcomes

  1. Heart rate variability measure

    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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Unidade Básica de Saúde
    Petrolina, Pernambuco, Brazil
08

References and documents

Publications

  • 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. PubMed 24582191 ↗
  • 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. PubMed 26467494 ↗
  • 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. PubMed 34787298 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03216317
Lead sponsor
Hospital Israelita Albert Einstein
Responsible party
Sponsor
First posted
Jul 13, 2017
Start date
Jul 15, 2017
Primary completion
Dec 30, 2017
Completion
Jul 30, 2018
Last update
Feb 8, 2019

Study contacts

Raphael MR Dias, PhD
principal investigator · Hospital Israelita Albert Einstein

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion