Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients

NCT02742220 | Completed

• 1 other identifier: IHT PAD
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

intermittent claudication; exercise; blood pressure; cardiovascular system

Outcome Measures

Primary Outcomes (1)

• Change from baseline in blood pressure at 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).

  Baseline and eight weeks

Secondary Outcomes (3)

• Change from baseline in autonomic cardiac modulation at eight weeks

  Baseline and eight weeks

• Change from baseline in vasodilatory capacity at eight weeks

  Baseline and eight weeks

• Change from baseline in arterial stiffness at eight weeks

  Baseline and eight weeks

Study Arms (2)

Isometric Handgrip Training Group

EXPERIMENTAL

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

Other: Isometric Handgrip Training Group

Control Group

SHAM COMPARATOR

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

Other: Control Group

Interventions

Isometric Handgrip Training Group 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.

Also known as: Isometric resistance exercise

Isometric Handgrip Training Group

Control Group 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.

Control Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pernambuco: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Israel Institute of Education and Research Albert Einstein

São Paulo, 05652-900, Brazil

Location

Related Publications (1)

• A Correia M, Oliveira PL, Farah BQ, Vianna LC, Wolosker N, Puech-Leao P, Green DJ, Cucato GG, Ritti-Dias RM. Effects of Isometric Handgrip Training in Patients With Peripheral Artery Disease: A Randomized Controlled Trial. J Am Heart Assoc. 2020 Feb 18;9(4):e013596. doi: 10.1161/JAHA.119.013596. Epub 2020 Feb 6.

  PMID: 32067595 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Raphael Ritti-Dias, PhD

  Israel Institute of Education and Research Albert Einstein

  PRINCIPAL INVESTIGATOR

• Gabriel Cucato, PhD

  Israel Institute of Education and Research Albert Einstein

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 18, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

BR (1)