Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Isometric Handgrip Training on Blood Pressure Reduction in Patients With Peripheral Artery Disease: A Randomized Clinical Trial

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Other: Isometric Handgrip Training Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isometric Handgrip Training Group<br>Experimental group will perform home-based unilateral handgrip exercise and will be recommended to increase daily physical activity levels. | Other: Isometric Handgrip Training Group<br>* Intervention period will last eight weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of four unilateral sets (dominant arm) with two minutes of isometric contraction, with 30% of maximum voluntary contraction, and four minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. Visits will be scheduled at weeks 1 and 5 to provide feedback to individuals, discuss possible problems during the training and adjust the intensity of the exercise. In addition the patients be recommended to increase daily physical activity levels, and weekly, there will be phone contacts with the patients to reinforce the exercise recommendations.<br>* Other names: Isometric resistance exercise;|
| Sham Comparator: Control Group<br>Control group will be recommended to increase daily physical activity levels. | Other: Control Group<br>* Intervention period will last eight weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood pressure at 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). | Baseline and eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in autonomic cardiac modulation at eight weeks | Cardiac autonomic modulation will be measured before and after eight weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA). | Baseline and eight weeks | 
| Change from baseline in vasodilatory capacity at eight weeks | Vasodilatory capacity will be measured before and after eight weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands). | Baseline and eight weeks | 
| Change from baseline in arterial stiffness at eight weeks | Arterial stiffness will be measured before and after eight weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia). | Baseline and eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermittent claudication, exercise, blood pressure, cardiovascular system