Handgrip Training in Patients With Peripheral Artery Disease (Isopress_03)

University of Nove de Julho

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Other: Control Group; Other: Isometric handgrip training

Study type: Interventional

Funder types: Other

Identifiers

NCT03663777

ISO003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Isometric Handgrip Training

Experimental group

Description:

Experimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels.

Treatment:

Other: Isometric handgrip training

Control group

Other group

Description:

Control gorup will be recommended to increase daily physical activity level

Treatment:

Other: Control Group