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临床试验/NCT03896334
NCT03896334已完成不适用

Effect of Isometric Handgrip Training on Ambulatory Blood Pressure: a Multi-center Study

Universidade Federal de Santa Catarina5 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2019年4月5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
入组人数
139
试验地点
5
主要终点
Change in ambulatory systolic blood pressure

研究概览

简要总结

Meta-analysis studies have demonstrated that isometric training with handgrip promotes reductions in clinical blood pressure, reaching 8 mmHg for systolic blood pressure and 4 mmHg for diastolic. However, the effects of this training modality on ambulatory blood pressure, which is better discriminant of cardiovascular risk than clinical BP, remains uncertain. Thus, the ISOPRESS Network, consists of researchers from Brazilian institutions of education and research (Federal University of Santa Catarina, Federal University of Amazonas, Federal University of Sergipe, Federal Rural University of Pernambuco and Universidade Nove de Julho), will conduct a multi-center study to analyze the effects of isometric handgrip training on clinic and 24-h ambulatory blood pressure in patients with hypertension. For this, each research center will conduct a randomized controlled trial with medicated patients with hypertension, of both sex. The participants will be randomized into two groups: isometric handgrip training group (HBT: n = 25 per center) and control group (CG: n = 25 per center).Subjects assigned to the HBT will train three times per week, four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction, during 24 weeks. Subjects randomized to the CG will perform stretching and relaxation exercises three times per week, during 24 weeks. The evaluations will occur in three moments: baseline, post-12 and post-24 weeks. The primary outcome will be ambulatory blood pressure, while clinic blood pressure and cardiac autonomic modulation will be analyzed as secondary outcomes. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. 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

  • •Diagnosis of hypertension, controlled by up to three antihypertensive medications
  • •Blood pressure levels between 130 and 180 mmHg
  • •No high cardiovascular risk (no other cardiovascular, metabolic or pulmonary disease nor any signals or symptoms of these disease)
  • •Not engaged in a physical exercise program for at least six months
  • •Not present cognitive impairment (Montreal Cognitive Assessment ≥ 26 points)

排除标准

  • •Adherence to less than 85% of training sessions
  • •Diagnosis of other cardiovascular diseases or diabetes during the course of the study
  • •Adherence to another supervised physical exercise program
  • •Change in medication class and/ or dose during the study
  • •Aggravation of the disease (i.e. blood pressure above 180 or use of four or more medications).

研究组 & 干预措施

Isometric handgrip training

Experimental

All participants that will be assigned to supervised isometric handgrip training will train three times per week, during 24 weeks. They will perform a bout of isometric handgrip exercise: four sets of 2-min of isometric contractions (using alternate hands) at 30% of maximal voluntary contraction.

干预措施: Supervised Isometric Handgrip Training (Behavioral)

Control group

Sham Comparator

All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.

干预措施: Sham comparator - stretching and relaxation exercises (Behavioral)

结局指标

主要结局

Change in ambulatory systolic blood pressure

时间窗: Baseline, 12 weeks 24 weeks

24h-ambulatory blood pressure monitoring

Change in ambulatory diastolic blood pressure

时间窗: Baseline, 12 weeks 24 weeks

24h-ambulatory blood pressure monitoring

Change in ambulatory mean blood pressure

时间窗: Baseline, 12 weeks 24 weeks

24h-ambulatory blood pressure monitoring

次要结局

  • Change in heart rate variability(Baseline, 12 weeks 24 weeks)
  • Change in clinic diastolic blood pressure(Baseline, 12 weeks 24 weeks)
  • Change in clinic mean blood pressure(Baseline, 12 weeks 24 weeks)
  • Change in clinic systolic blood pressure(Baseline, 12 weeks 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aline Mendes Gerage

Principal Investigator

Universidade Federal de Santa Catarina

研究点 (5)

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