Handgrip Training in Patients With Peripheral Artery Disease

ConditionPeripheral Arterial Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45+

SponsorUniversity of Nove de Julho

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Isometric handgrip training
Other intervention
Intervention period will last 12 weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of eight sets of bilateral handgrip contraction of two minutes of isometric contraction, with 30% of maximum voluntary contraction, and two minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. 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.
Control Group
Other intervention
Intervention period will last 12 weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Isometric Handgrip TrainingExperimental treatment 1 intervention

Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

Change from baseline in blood pressure at 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).

Time frame

Baseline and 12 weeks

Secondary outcomes

Change from baseline in cardiac autonomic modulation at 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).

Time frame

Baseline and 12 weeks

Sponsors and contacts

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University of Nove de Julho

Lead sponsor

Hospital Israelita Albert Einstein

Collaborator

Source ClinicalTrials.gov

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