Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

Sponsor
University of Pernambuco (Other)
Overall Status
Completed
CT.gov ID
NCT02348138
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnólogico - CNPQ (Other), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other), Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco (Other)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Isometric handgrip training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in office blood pressure [Baseline and 12 weeks]

    Secondary Outcome Measures

    1. Change in ambulatory blood pressure [Basaline and 12 weeks]

    2. Change in central blood pressure [Basaline and 12 weeks]

    3. Change in cardiac autonomic modulation [Baseline and 12 weeks]

    4. Change in vasodilatory capacity [Baseline and 12 weeks]

    5. Change in arterial stiffness [Baseline and 12 weeks]

    6. Change in markers of oxidative stress [Baseline and 12 weeks]

    7. Change in markers of inflammation [Baseline and 12 weeks]

    Other Outcome Measures

    1. Adherence to training [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 [Baseline and 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pernambuco Recife Pernambuco Brazil 50100-130

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Raphael M Ritti-Dias, Doctor, University of Pernambuco
    • Principal Investigator: Breno Q Farah, Phd student, University of Pernambuco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Breno Quintella Farah, PhD student, University of Pernambuco
    ClinicalTrials.gov Identifier:
    NCT02348138
    Other Study ID Numbers:
    • ISOPRESS
    First Posted:
    Jan 28, 2015
    Last Update Posted:
    Oct 4, 2017
    Last Verified:
    Oct 1, 2017
    Keywords provided by Breno Quintella Farah, PhD student, University of Pernambuco
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 4, 2017