Handgrip Training in Patients With Peripheral Artery Disease

NCT03663777 | Recruiting DMC

• 1 other identifier: ISO003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 12 weeks

Secondary Outcomes (1)

• Change from baseline in cardiac autonomic modulation at 12 weeks

  Baseline and 12 weeks

Study Arms (2)

Isometric Handgrip Training

EXPERIMENTAL

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

Other: Isometric handgrip training

Control group

OTHER

Control gorup will be recommended to increase daily physical activity level

Other: Control Group

Interventions

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.

Also known as: Isometric resistance exercise

Isometric Handgrip Training

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.

Control group

Eligibility Criteria

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

You may qualify if:

• 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

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 Nove de Julho: lead
• Hospital Israelita Albert Einstein: collaborator

Study Sites (2)

Universidade Nove de Julho

São Paulo, São Paulo, 01525-000, Brazil

RECRUITING

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

COMPLETED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Raphael Dias, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

• Marilia Correia, PhD

  University of Nove de Julho

  STUDY CHAIR

Central Study Contacts

Raphael Dias, PhD

CONTACT

+5519999406878; raphaelritti@gmail.com

Marilia Correia, PhD

CONTACT

+5511999711669; marilia.correia@live.com

Study Design

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

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 10, 2018
• Study Start: August 1, 2018
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After 1 year after the end of recruitment

Locations

BR (2)