Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Handgrip Training in Patients With Peripheral Artery Disease

NCT03663777

Peripheral Arterial Disease

RECRUITING NA

Isometric Handgrip Exercise for Blood Pressure Management

NCT02458443

Hypertension

COMPLETED NA

Isometric Handgrip Exercise for Blood Pressure Management

NCT02458456

Hypertension

COMPLETED NA

Inspiratory Muscle Training in Pulmonary Hypertension

NCT03102294

Chronic Thromboembolic Pulmonary Hypertension Inspiratory Muscle Training Inspiratory Muscle Weakness +1 more

COMPLETED NA

Exercise Intermittent Isometric Handgrip and Blood Flow Restriction

NCT02384161

Sarcopenia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Isometric Handgrip Training Group

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

Group Type EXPERIMENTAL

Isometric Handgrip Training Group

Intervention Type OTHER

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.

Control Group

Control group will be recommended to increase daily physical activity levels.

Group Type SHAM_COMPARATOR

Control Group

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Isometric Handgrip Training Group

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.

Intervention Type OTHER

Control Group

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Isometric resistance exercise

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No