Clinical trial NCT02742220: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: intermittent claudication
exercise
blood pressure
cardiovascular system
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-04-18
Enrollment: 102
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 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.

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.

Primary outcomes:
measure: Change from baseline in blood pressure at eight weeks
timeFrame: Baseline and eight weeks
Secondary outcomes:
measure: Change from baseline in autonomic cardiac modulation at eight weeks
timeFrame: Baseline and eight weeks
measure: Change from baseline in vasodilatory capacity at eight weeks
timeFrame: Baseline and eight weeks
measure: Change from baseline in arterial stiffness at eight weeks
timeFrame: Baseline and eight weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Israel Institute of Education and Research Albert Einstein
Study officials:
affiliation: Israel Institute of Education and Research Albert Einstein
name: Raphael Ritti-Dias, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Israel Institute of Education and Research Albert Einstein
name: Gabriel Cucato, PhD
role: STUDY_DIRECTOR
References:
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.