Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Nove de Julho
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Change from baseline in blood pressure at 12 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Isometric Handgrip Training
Experimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels.
Intervention: Isometric handgrip training (Other)
Control group
Control gorup will be recommended to increase daily physical activity level
Intervention: Control Group (Other)
Outcomes
Primary Outcomes
Change from baseline in blood pressure at 12 weeks
Time Frame: 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 Outcomes
- Change from baseline in cardiac autonomic modulation at 12 weeks(Baseline and 12 weeks)
Investigators
Raphael Mendes Ritti Dias
Professor
University of Nove de Julho