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CompletedNCT02348138Updated Oct 4, 2017

Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

An interventional study of Isometric handgrip training in Hypertension, sponsored by University of Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-04.

Sponsored by University of Pernambuco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypertension

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Keywords

  • Isometric Handgrip
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 72 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Pernambuco is the lead sponsor of 27 studies on the registry; 4 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

  • 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherIsometric 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.

    Also known as: Exercise

06

What researchers measure

Primary outcomes

  1. Change in office blood pressure

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change in ambulatory blood pressure

    Time frame: Basaline and 12 weeks

  2. Change in central blood pressure

    Time frame: Basaline and 12 weeks

  3. Change in cardiac autonomic modulation

    Time frame: Baseline and 12 weeks

  4. Change in vasodilatory capacity

    Time frame: Baseline and 12 weeks

  5. Change in arterial stiffness

    Time frame: Baseline and 12 weeks

  6. Change in markers of oxidative stress

    Time frame: Baseline and 12 weeks

  7. Change in markers of inflammation

    Time frame: Baseline and 12 weeks

Other outcomes

  1. Adherence to training

    Adherence to training will be evaluated by the number of subjects who completed the two types of training

    Time frame: 12 weeks

  2. Change in handgrip strength

    Time frame: Baseline and 12 weeks

07

Study locations

1 site
  • University of Pernambuco
    Recife, Pernambuco 50100-130, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02348138
Lead sponsor
University of Pernambuco
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnólogico - CNPQ, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Ciência e Tecnologia de Pernambuco
Responsible party
Breno Quintella Farah (PhD student, University of Pernambuco) — Principal investigator
First posted
Jan 28, 2015
Start date
Jun 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Oct 4, 2017

Study contacts

Raphael M Ritti-Dias, Doctor
study director · University of Pernambuco
Breno Q Farah, Phd student
principal investigator · University of Pernambuco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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

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