Clinical trial NCT02348138: Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives
Official title: Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Isometric Handgrip
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnólogico - CNPQ
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Ciência e Tecnologia de Pernambuco
First posted: 2015-01-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose this study is to analyze the effects of isometric handgrip training on cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under anti-hypertensive medication, will be selected and randomly distributed into three groups: home-based isometric handgrip training (HBT), supervised isometric handgrip training (ST) and control group (CG).Subjects assigned to the HBT and ST will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction. However, the subjects of the HBT group conduct the training without daily supervision. Subjects randomized to the CG will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations.Baseline and after 12 weeks of intervention, the following cardiovascular risk indicators will be obtained: blood pressure, arterial stiffness, cardiac autonomic modulation, vasodilatory capacity and oxidative and inflammatory stress markers, in addition to microalbuminuria. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. If the premises of this test are met. The level of significance that will be adopted is p\<0.05.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension;
* Must be under anti-hypertensive medications of three months or more;
* May not present diabetes or other cardiovascular diseases;
* May not engaged in regular physical activity;
* May not have disabilities that compromise the physical activity practices.

Exclusion Criteria:

* Not perform more than 85% of the training sessions;
* Present diagnosis of metabolic diseases, cardiovascular or pulmonary during the study;
* Adherence to other physical activity program beyond the training offered by this study;
* Change in class and / or dose of medication during the study;
* Not using the medication regularly;
* Worsening of the disease.

Primary outcomes:
measure: Change in office blood pressure
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in ambulatory blood pressure
timeFrame: Basaline and 12 weeks
measure: Change in central blood pressure
timeFrame: Basaline and 12 weeks
measure: Change in cardiac autonomic modulation
timeFrame: Baseline and 12 weeks
measure: Change in vasodilatory capacity
timeFrame: Baseline and 12 weeks
measure: Change in arterial stiffness
timeFrame: Baseline and 12 weeks
measure: Change in markers of oxidative stress
timeFrame: Baseline and 12 weeks
measure: Change in markers of inflammation
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Adherence to training
timeFrame: 12 weeks
measure: Change in handgrip strength
timeFrame: Baseline and 12 weeks
Locations:
city: Recife
country: Brazil
facility: University of Pernambuco
state: Pernambuco
Study officials:
affiliation: University of Pernambuco
name: Raphael M Ritti-Dias, Doctor
role: STUDY_DIRECTOR
affiliation: University of Pernambuco
name: Breno Q Farah, Phd student
role: PRINCIPAL_INVESTIGATOR
References: