Clinical trial NCT03663777: Handgrip Training in Patients With Peripheral Artery Disease
Official title: Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Hospital Israelita Albert Einstein
First posted: 2018-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in blood pressure at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in cardiac autonomic modulation at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: University of Nove de Julho
name: Raphael Dias, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nove de Julho
name: Marilia Correia, PhD
role: STUDY_CHAIR
References: