Effects of Isometric Handgrip Training on Blood Pressure Reduction in Patients With Peripheral Artery Disease: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change from baseline in blood pressure at eight weeks
研究概览
简要总结
The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60 patients which will be randomized into 2 groups (30 per group), IHT and control group (CG). IHT group will training isometric contraction for 8 weeks. The GC patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, brachial and central blood pressure will be measured.
详细描述
Meta-analyze studies have shown that IHT promotes reductions in blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg. However, remain uncertain the effects of this type of training on BP in patients with more severe cardiovascular diseases such as peripheral artery disease. Because this type of training which requires approximately 20 minutes per session and does not require supervision, it is possible that this intervention is interesting to reduce BP of these patients. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60 patients, which will be randomized into 2 groups (30 per group), IHT and control group (CG). IHT group will hold three sessions per week with four unilateral sets with two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of four minutes between them, for 8 weeks. The GC patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, is going to be evaluated functional capacity, brachial and central BP, arterial stiffness, cardiovascular autonomic modulation and muscle vasodilation. Will be used to analyze two-factor variance for repeated measures, with group (IHT and GC) and the time (before and after 8 weeks) as factors and the post-hoc test of Newman-Keuls.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postmenopausal without hormone therapy replacement, if woman;
- •present peripheral artery disease (ankle brachial index < 0.90) in one or both lower limbs;
- •do not present neurological / cognitive diseases;
- •is able to practice home-based exercise;
排除标准
- •patients will only be excluded if they make any medication changes before completing the intervention period or present any health problems that prevent physical activity.
研究组 & 干预措施
Isometric Handgrip Training Group
Experimental group will perform home-based unilateral handgrip exercise and will be recommended to increase daily physical activity levels.
干预措施: Isometric Handgrip Training Group (Other)
Control Group
Control group will be recommended to increase daily physical activity levels.
干预措施: Control Group (Other)
结局指标
主要结局
Change from baseline in blood pressure at eight weeks
时间窗: Baseline and eight weeks
Blood pressure will be measured before and after eight weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
次要结局
- Change from baseline in arterial stiffness at eight weeks(Baseline and eight weeks)
- Change from baseline in autonomic cardiac modulation at eight weeks(Baseline and eight weeks)
- Change from baseline in vasodilatory capacity at eight weeks(Baseline and eight weeks)
研究者
Raphael M. Ritti Dias
PhD
University of Pernambuco