Handgrip Training in Patients With Peripheral Artery Disease
- Conditions
- Peripheral Arterial Disease
- Interventions
- Other: Isometric handgrip trainingOther: Control Group
- Registration Number
- NCT03663777
- Lead Sponsor
- University of Nove de Julho
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Isometric Handgrip Training Isometric handgrip training Experimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels. Control group Control Group Control gorup will be recommended to increase daily physical activity level
- Primary Outcome Measures
Name Time Method Change from baseline in blood pressure at 12 weeks 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).
- Secondary Outcome Measures
Name Time Method Change from baseline in cardiac autonomic modulation at 12 weeks Baseline and 12 weeks Cardiac autonomic modulation will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
Trial Locations
- Locations (2)
Hospital Israelita Albert Einstein
🇧🇷São Paulo, Brazil
Universidade Nove de Julho
🇧🇷São Paulo, Brazil