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Clinical Trials/NCT02348138
NCT02348138CompletedNot Applicable

Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

University of Pernambuco1 site in 1 country72 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
72
Locations
1
Primary Endpoint
Change in office blood pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Home-based isometric handgrip training

Experimental

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.

Intervention: Isometric handgrip training (Other)

Supervised isometric handgrip training

Experimental

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.

Intervention: Isometric handgrip training (Other)

Control group

No Intervention

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

Outcomes

Primary Outcomes

Change in office blood pressure

Time Frame: Baseline and 12 weeks

Secondary Outcomes

  • Change in ambulatory blood pressure(Basaline and 12 weeks)
  • Change in central blood pressure(Basaline and 12 weeks)
  • Change in cardiac autonomic modulation(Baseline and 12 weeks)
  • Change in vasodilatory capacity(Baseline and 12 weeks)
  • Change in arterial stiffness(Baseline and 12 weeks)
  • Change in markers of oxidative stress(Baseline and 12 weeks)
  • Change in markers of inflammation(Baseline and 12 weeks)

Investigators

Sponsor
University of Pernambuco
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Breno Quintella Farah

PhD student

University of Pernambuco

Study Sites (1)

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