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Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Isometric Handgrip Training Group
Control Group
Sponsored by
University of Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring intermittent claudication, exercise, blood pressure, cardiovascular system

Eligibility Criteria

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

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.

Sites / Locations

  • Israel Institute of Education and Research Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Isometric Handgrip Training Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change from baseline in autonomic cardiac modulation at eight weeks
Cardiac autonomic modulation will be measured before and after eight weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
Change from baseline in vasodilatory capacity at eight weeks
Vasodilatory capacity will be measured before and after eight weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands).
Change from baseline in arterial stiffness at eight weeks
Arterial stiffness will be measured before and after eight weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia).

Full Information

First Posted
April 4, 2016
Last Updated
February 1, 2018
Sponsor
University of Pernambuco
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02742220
Brief Title
Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients
Official Title
Effects of Isometric Handgrip Training on Blood Pressure Reduction in Patients With Peripheral Artery Disease: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pernambuco
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
intermittent claudication, exercise, blood pressure, cardiovascular system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isometric Handgrip Training Group
Arm Type
Experimental
Arm Description
Experimental group will perform home-based unilateral handgrip exercise and will be recommended to increase daily physical activity levels.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Control group will be recommended to increase daily physical activity levels.
Intervention Type
Other
Intervention Name(s)
Isometric Handgrip Training Group
Other Intervention Name(s)
Isometric resistance exercise
Intervention Description
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
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in blood pressure at eight weeks
Description
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).
Time Frame
Baseline and eight weeks
Secondary Outcome Measure Information:
Title
Change from baseline in autonomic cardiac modulation at eight weeks
Description
Cardiac autonomic modulation will be measured before and after eight weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
Time Frame
Baseline and eight weeks
Title
Change from baseline in vasodilatory capacity at eight weeks
Description
Vasodilatory capacity will be measured before and after eight weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands).
Time Frame
Baseline and eight weeks
Title
Change from baseline in arterial stiffness at eight weeks
Description
Arterial stiffness will be measured before and after eight weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia).
Time Frame
Baseline and eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Ritti-Dias, PhD
Organizational Affiliation
Israel Institute of Education and Research Albert Einstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriel Cucato, PhD
Organizational Affiliation
Israel Institute of Education and Research Albert Einstein
Official's Role
Study Director
Facility Information:
Facility Name
Israel Institute of Education and Research Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The IPD data to be shared are the indivividual and mean data of blood pressure responses to eight weeks of isometric handgrip training.
Citations:
PubMed Identifier
32067595
Citation
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.
Results Reference
derived

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Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients

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