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临床试验/NCT02348138
NCT02348138已完成不适用

Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

University of Pernambuco1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Change in office blood pressure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: 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.

干预措施: 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

结局指标

主要结局

Change in office blood pressure

时间窗: Baseline and 12 weeks

次要结局

  • 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)

研究者

发起方
University of Pernambuco
申办方类型
Other
责任方
Principal Investigator
主要研究者

Breno Quintella Farah

PhD student

University of Pernambuco

研究点 (1)

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