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NCT Number: NCT03663777

Handgrip Training in Patients With Peripheral Artery Disease

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isometric Handgrip Training

Other

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.

Other names: Isometric resistance exercise

Control Group

Other

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.

Primary outcomes

  1. 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

  1. Change from baseline in cardiac autonomic modulation at 12 weeks

    Time frame: Baseline and 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marilia Correia, PhD

CONTACT

[email protected]

+5511999711669

Raphael Dias, PhD

CONTACT

[email protected]

+5519999406878

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Hospital Israelita Albert Einstein

Registry information

Official study title

Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease

Acronym: Isopress_03

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2018
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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