Handgrip Training in Patients With Peripheral Artery Disease (Isopress_03)

• ClinicalTrials.gov Identifier: NCT03663777
• Recruitment Status: Suspended
• First Posted: September 10, 2018
• Last Update Posted: October 6, 2021
• Sponsor: University of Nove de Julho
• Collaborator: Hospital Israelita Albert Einstein
• Information provided by (Responsible Party): Raphael Mendes Ritti Dias, University of Nove de Julho

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Other: Isometric handgrip training; Other: Control Group	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease
• Actual Study Start Date: August 1, 2018
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Isometric Handgrip Training; Experimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels.	Other: Isometric handgrip training; 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 Name: Isometric resistance exercise
Control group; Control gorup will be recommended to increase daily physical activity level	Other: Control Group; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05652-900

Sponsors and Collaborators

University of Nove de Julho

Hospital Israelita Albert Einstein

Investigators

• Principal Investigator: Raphael Dias, PhD; University of Nove de Julho

More Information

• Responsible Party: Raphael Mendes Ritti Dias, Professor, University of Nove de Julho
• ClinicalTrials.gov Identifier: NCT03663777
• Other Study ID Numbers: ISO003
• First Posted: September 10, 2018
• Last Update Posted: October 6, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: WE plan to share the data upon requirement
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• Time Frame: After 1 year after the end of recruitment

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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