Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

Hypertension Clinical Trial

Official title:

Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348138
• Other study ID #: ISOPRESS
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: October 2, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Isometric handgrip training
The two experimental groups (HBT and ST) will receive intervention with isometric handgrip exercise for 12 weeks, and the HBT group without daily supervision.

Locations

Country	Name	City	State
Brazil	University of Pernambuco	Recife	Pernambuco

Sponsors (4)

Lead Sponsor	Collaborator
University of Pernambuco	Conselho Nacional de Desenvolvimento Científico e Tecnólogico - CNPQ, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to training	Adherence to training will be evaluated by the number of subjects who completed the two types of training	12 weeks
Other	Change in handgrip strength		Baseline and 12 weeks
Primary	Change in office blood pressure		Baseline and 12 weeks
Secondary	Change in ambulatory blood pressure		Basaline and 12 weeks
Secondary	Change in central blood pressure		Basaline and 12 weeks
Secondary	Change in cardiac autonomic modulation		Baseline and 12 weeks
Secondary	Change in vasodilatory capacity		Baseline and 12 weeks
Secondary	Change in arterial stiffness		Baseline and 12 weeks
Secondary	Change in markers of oxidative stress		Baseline and 12 weeks
Secondary	Change in markers of inflammation		Baseline and 12 weeks