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
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Other: Isometric handgrip training Other: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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 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.
- 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).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663777
|Contact: Raphael Dias, PhDfirstname.lastname@example.org|
|Hospital Israelita Albert Einstein||Recruiting|
|São Paulo, Brazil, 05652-900|
|Contact: Gabriel Cucato|
|Principal Investigator: Gabriel Cucato, PhD|
|Principal Investigator:||Raphael Dias, PhD||University of Nove de Julho|