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Completed

NCT Number: NCT02348138

Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pernambuco

Recife, Pernambuco, 50100-130, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isometric Handgrip Training

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.

Other names: Exercise

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

    Time frame: 12 weeks

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

  2. Change in handgrip strength

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Ciência e Tecnologia de Pernambuco

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2015
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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