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Handgrip Training in Patients With Peripheral Artery Disease (Isopress_03)

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Isometric handgrip training
Control Group
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Nove de JulhoRecruiting
  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Isometric Handgrip Training

Control group

Arm Description

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

Control gorup will be recommended to increase daily physical activity level

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change from baseline in cardiac autonomic modulation at 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).

Full Information

First Posted
September 5, 2018
Last Updated
September 28, 2023
Sponsor
University of Nove de Julho
Collaborators
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT03663777
Brief Title
Handgrip Training in Patients With Peripheral Artery Disease
Acronym
Isopress_03
Official Title
Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isometric Handgrip Training
Arm Type
Experimental
Arm Description
Experimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels.
Arm Title
Control group
Arm Type
Other
Arm Description
Control gorup will be recommended to increase daily physical activity level
Intervention Type
Other
Intervention Name(s)
Isometric handgrip training
Other Intervention Name(s)
Isometric resistance exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in blood pressure at 12 weeks
Description
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).
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in cardiac autonomic modulation at 12 weeks
Description
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).
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael Dias, PhD
Phone
+5519999406878
Email
raphaelritti@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marilia Correia, PhD
Phone
+5511999711669
Email
marilia.correia@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Dias, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marilia Correia, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Nove de Julho
City
São Paulo
ZIP/Postal Code
01525-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilia Correia, PhD
Phone
(55 11) 999711669
Email
marilia.correia@live.com
First Name & Middle Initial & Last Name & Degree
Marilia Correia, PhD
First Name & Middle Initial & Last Name & Degree
Raphael Dias, PhD
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
WE plan to share the data upon requirement
IPD Sharing Time Frame
After 1 year after the end of recruitment

Learn more about this trial

Handgrip Training in Patients With Peripheral Artery Disease

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