An interventional study of Isometric Handgrip Training Group and Control Group in Peripheral Artery Disease, sponsored by University of Pernambuco. Completed at 1 site in Brazil. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by University of Pernambuco · Not applicable, Interventional, and Treatment
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 102 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University of Pernambuco is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Experimental group will perform home-based unilateral handgrip exercise and will be recommended to increase daily physical activity levels.
Other: Isometric Handgrip Training Group
Control group will be recommended to increase daily physical activity levels.
Other: Control Group
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.
Also known as: Isometric resistance exercise
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.
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).
Time frame: Baseline and eight weeks
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).
Time frame: Baseline and eight weeks
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).
Time frame: Baseline and eight weeks
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).
Time frame: Baseline and eight weeks
Plan to share: Undecided — The IPD data to be shared are the indivividual and mean data of blood pressure responses to eight weeks of isometric handgrip training.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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University of Pernambuco