Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change from baseline in blood pressure at 12 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 30 patients which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will training isometric contraction for 12 weeks. In CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention cardiovascular measures will be obtained.
详细描述
Meta-analyze studies have shown that 4 sets of 2 min of isometric handgrip training (IHT)reduces blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg in hypertensive patients after few weeks. However, using this protocol it was not observed any changes in BP in patients with peripheral artery disease. However, it is unknown whether reductions in BP does not occur after isometric handgrip training employing longer and protocol of IHT with more volume. 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 30 patients, which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will hold three sessions per week with eight sets of two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of two minutes between them, for 12 weeks. In the CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, BP and cardiac autonomic modulationwill be assessed. Will be used to analyze two-factor variance for repeated measures, with group (IHT and CG) and the time (before and after 12 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, Outcomes Assessor)
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
- •Women in post-menopause phase without hormone replacement therapy
- •Ankle-brachial index <0.90
- •Not severe obese (≥ 35kg/m2)
- •Not present amputation in the limbs
- •Have blood pressure levels lower than 160mmHg for systolic and 105mmHg for diastolic
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
Experimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels.
干预措施: Isometric handgrip training (Other)
Control group
Control gorup will be recommended to increase daily physical activity level
干预措施: Control Group (Other)
结局指标
主要结局
Change from baseline in blood pressure at 12 weeks
时间窗: Baseline and 12 weeks
Blood pressure will be measured before and after 12 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 cardiac autonomic modulation at 12 weeks(Baseline and 12 weeks)
研究者
Raphael Mendes Ritti Dias
Professor
University of Nove de Julho