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Handgrip Training in Patients With Peripheral Artery Disease (Isopress_03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663777
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Hospital Israelita Albert Einstein
Information provided by (Responsible Party):
Raphael Mendes Ritti Dias, University of Nove de Julho

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.

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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, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.




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).



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663777


Contacts
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Contact: Raphael Dias, PhD +5519999406878 raphaelritti@gmail.com

Locations
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Brazil
Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil, 05652-900
Contact: Gabriel Cucato         
Principal Investigator: Gabriel Cucato, PhD         
Sponsors and Collaborators
University of Nove de Julho
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: Raphael Dias, PhD University of Nove de Julho
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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    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases