Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives

NCT02348138 | Completed DMC

• 1 other identifier: ISOPRESS
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Isometric Handgrip

Outcome Measures

Primary Outcomes (1)

• Change in office blood pressure

  Baseline and 12 weeks

Secondary Outcomes (7)

• Change in ambulatory blood pressure

  Basaline and 12 weeks

• Change in central blood pressure

  Basaline and 12 weeks

• Change in cardiac autonomic modulation

  Baseline and 12 weeks

• Change in vasodilatory capacity

  Baseline and 12 weeks

• Change in arterial stiffness

  Baseline and 12 weeks

Other Outcomes (2)

• Adherence to training

  12 weeks

• Change in handgrip strength

  Baseline and 12 weeks

Study Arms (3)

Home-based isometric handgrip training

EXPERIMENTAL

All participants that will be assigned to home-based isometric handgrip training (HBT) 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 training will be performed without daily supervision. Therefore, the subjects will receive a logbook to record the exercise sessions. In addition, visits will be scheduled at weeks 1, 3, 6, 9 and 11 to provide feedback to individuals and discuss potential problems in conducting training.

Other: Isometric handgrip training

Supervised isometric handgrip training

EXPERIMENTAL

All participants that will be assigned to supervised isometric handgrip training (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 with. The training will be performed with daily supervision.

Other: Isometric handgrip training

Control group

NO INTERVENTION

Subjects randomized to the control group (CG) will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations

Interventions

Isometric handgrip training OTHER

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

Also known as: Exercise

Home-based isometric handgrip training; Supervised isometric handgrip training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pernambuco: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator

Study Sites (1)

University of Pernambuco

Recife, Pernambuco, 50100-130, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Raphael M Ritti-Dias, Doctor

  University of Pernambuco

  STUDY DIRECTOR

• Breno Q Farah, Phd student

  University of Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 28, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

BR (1)