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Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients

Not Applicable
Completed
Conditions
Peripheral Artery Disease
Interventions
Other: Isometric Handgrip Training Group
Other: Control Group
Registration Number
NCT02742220
Lead Sponsor
University of Pernambuco
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 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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
102
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Isometric Handgrip Training GroupIsometric Handgrip Training GroupExperimental group will perform home-based unilateral handgrip exercise and will be recommended to increase daily physical activity levels.
Control GroupControl GroupControl group will be recommended to increase daily physical activity levels.
Primary Outcome Measures
NameTimeMethod
Change from baseline in blood pressure at eight weeksBaseline 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).

Secondary Outcome Measures
NameTimeMethod
Change from baseline in arterial stiffness at eight weeksBaseline and 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).

Change from baseline in autonomic cardiac modulation at eight weeksBaseline and 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).

Change from baseline in vasodilatory capacity at eight weeksBaseline and 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).

Trial Locations

Locations (1)

Israel Institute of Education and Research Albert Einstein

🇧🇷

São Paulo, Brazil

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