<?xml version="1.0" encoding="UTF-8"?>

<!DOCTYPE trials SYSTEM "http://localhost:8000/xml/opentrials.dtd">
<trials version="1">
    
    <trial language="en"
           status="published"
           date_registration="2011-07-03"
           created="2011-05-18"
           updated="2011-07-03">
        <trial_identification>
            <trial_id>RBR-8mx5g6</trial_id>
            <utrn_number>U1111-1121-5553</utrn_number>
            <reg_name>REBEC</reg_name>
            <public_title>Influence of captopril use on blood pressure response measured after a single bout of strength exercise in men with high blood pressure</public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Effect of captopril use on blood pressure response after a single bout of resistance exercise in hypertensive men</scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
        </trial_identification>

        <sponsors_and_support>
            <primary_sponsor country_code="BR" type="other">
                <name>Escola de Educação Física e Esporte da Universidade de São Paulo</name>
                <address>Av. Prof. Mello Moraes, 65 - Butantã</address>
                <state></state>
                <city></city>
            </primary_sponsor>

            
            <secondary_sponsor country_code="BR" type="other">
                <name>Laboratório de Hipertensão do Hospital das Clínicas da Faculdade de Medicina da USP</name>
                <address>Av. Enéas de Carvalho Aguiar, 255 7o andar, 7114</address>
                <state></state>
                <city></city>
            </secondary_sponsor>
            

            
            <source_support country_code="BR" type="other">
                <name>Pro Reitoria de Graduação da Universidade de São Paulo</name>
                <address>Rua da Praça do Relógio, 109 - BUtantã - </address>
                <state></state>
                <city></city>
            </source_support>
            
            <source_support country_code="BR" type="state_research_support_foundation">
                <name>Fundação de Amparo à Pesquisa do Estado de São Paulo</name>
                <address>Rua Pio XI, 1500 - 05468-901</address>
                <state></state>
                <city></city>
            </source_support>
            
        </sponsors_and_support>

        <health_conditions>
            
            <hc_code vocabulary="decs" version="" code="C14">
                <text>Cardiovascular diseases</text>
                
                
                <text_translation lang="es">Enfermedades cardiovasculares</text_translation>
                
                <text_translation lang="pt-br">Doenças cardiovasculares</text_translation>
                
                
            </hc_code>
            

            
            <keyword vocabulary="decs" version="" code="C14.907.489">
                <text>Hypertension</text>
                
                
                <text_translation lang="es">Hipertensión</text_translation>
                
                <text_translation lang="pt-br">Hipertensão</text_translation>
                
                
            </keyword>
            

            <freetext>Hypertension</freetext>
        </health_conditions>

        <interventions>
            
            <i_code value="drug"></i_code>
            
            <i_code value="other"></i_code>
            

            
            <keyword vocabulary="decs" version="" code="F01.145.632">
                <text>Motor Activity</text>
                
                
                <text_translation lang="es">Actividad Motora</text_translation>
                
                <text_translation lang="pt-br">Atividade Motora</text_translation>
                
                
            </keyword>
            
            <keyword vocabulary="decs" version="" code="D27.505.519.389.745.085">
                <text>Angiotensin-Converting Enzyme Inhibitors</text>
                
                
                <text_translation lang="es">Inhibidores de la Enzima Convertidora de Angiotensina</text_translation>
                
                <text_translation lang="pt-br">Inibidores da Enzima Conversora da Angiotensina</text_translation>
                
                
            </keyword>
            

            <freetext>Groups: normotensives and hypertensives
Normotensives: Evaluated without any teraphy
Hypertensives: different oral therapies, administered for 4 weeks each (random and double blinded). Therapies = captopril (50-75mg, 3 times a day) and placebo (3cp/day).
</freetext>
        </interventions>

        <recruitment status="not_yet_recruiting">
            
            <recruitment_country value="BR"></recruitment_country>
            

            <inclusion_criteria>Men
Aged between 30 and 60 years
Non smokers
Physically inactives (did not perform physical activity more than twice a week)
Normotensives and hypertensives will form different groups
Hypertensives should not have end organ damage or secondary causes of hypertension according to the diagnotic rotine of the Hypertension League of Clinical Hospital, Faculty of Medicine, USP.  </inclusion_criteria>
            <exclusion_criteria>Subjects with obesity (body mass index equal or greater than 30 kg/m2)
Subjects with diabetes (fasting glycemia equal or greater than 126 mg/dl)
Subjects with cardiac diseases (previous diagnosis or alteration on resting or exercise ECG)
Subjects who do not tolerate the study medication</exclusion_criteria>
            <gender value="male"></gender>
            <agemin value="30" unit="years"></agemin>
            <agemax value="60" unit="years"></agemax>

            
            <date_enrolment_actual start="2011-07-01" end="None"></date_enrolment_actual>
            

            <target_size value="24"></target_size>
        </recruitment>

        <study expanded_access_program="False"
               number_of_arms="2">
            <study_design>Randomized controlled clinical trial, with 2 arms, phase 4,  double-blinded.</study_design>
            <type value="Intervention"></type>
            <phase value="4"></phase>
            <purpose value="treatment"></purpose>
            <intervention_assignment value="cross-over"></intervention_assignment>
            <masking value="double-blind"></masking>
            <allocation value="randomized-controlled"></allocation>
        </study>

        <outcomes>
            
            <primary_outcome value="post-exercise hypotension - evaluated by the measurement of clinic (auscultatory) and ambulatorial (oscillometric) blood pressure before and after rest and resistance exercise while receiving placebo and captopril.">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Hipotensão pós-exercício - avaliado pela medida da pressão arterial cliníca (auscultatória) e ambulatorial (oscilométrica) antes e após o repouso e o exercício resistido durante a utilização de placebo e captopril." lang="pt-br"></outcome_translation>
                
            </primary_outcome>
            

            
            <secondary_outcome value="hemodynamics - evaluated by the measurement of cardiac output (CO2 rebreathing)and heart hate (ECG) performed before and after rest and resistance exercise while receiving placebo and captopril. Systemic vascular resistance and stroke volume will be calculated.">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Hemodinâmica - avaliada pela medida do débito cardíaco (reinalação de gás carbônico) e da frequência cardíaca (ECG) antes e após o repouso e o exercício resistido durante a utilização de placebo e captopril. A partir desse dados a resistência vascular periférica e o volume sistolico serão calculados." lang="pt-br"></outcome_translation>
                
            </secondary_outcome>
            
            <secondary_outcome value="Autonomic modulation - evaluated by the measurement of heart rate and blood pressure variabilities (spectral analysis) performed before and after rest and resistance exercise while receiving placebo and captopril">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Regulação autonômica - avaliada pela medida da variabilidade da frequência cardíaca e da pressão arterial (análise espectral) realizada antes e após o repouso e o exercício resistido durante a utilização de placebo e captopril. " lang="pt-br"></outcome_translation>
                
            </secondary_outcome>
            
            <secondary_outcome value="Vascular function - evaluated by the measurement of baseline blood flow and its response to the reactive hyperemia maneuver (venous occlusion pletismography) performed before and after rest and resistance exercise while receiving placebo and captopril.">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Função vascular - avaliada pela medida do fluxo sanguíneo basal e de sua resposta à manobra de hiperemia reativa (pletismografia de oclusão venosa) realizada antes e após o repouso e o exercício resistido durante a utilização de placebo e captopril. " lang="pt-br"></outcome_translation>
                
            </secondary_outcome>
            
        </outcomes>

        <contacts>
            
            <person pid="108" country_code="BR">
                <firstname>Claudia</firstname>
                <middlename>Lucia de Moraes</middlename>
                <lastname>Forjaz</lastname>
                <address>Av. Prof. Mello Moraes, 65 - Butantã</address>
                <city>São Paulo</city>
                <zip>05508030</zip>
                <telephone>551130913136</telephone>
                <email>cforjaz@usp.br</email>
                
                <affiliation country_code="BR" type="other">
                    <name>Escola de Educação Física e Esporte da Universidade de São Paulo</name>
                    <address>Av. Prof. Mello Moraes, 65 - Butantã</address>
                </affiliation>
                
            </person>
            

            
            <public_contact person="108"></public_contact>
            

            
            <scientific_contact person="108"></scientific_contact>
            

            
            <site_contact person="108"></site_contact>
            
        </contacts>

        <secondary_ids>
            
            <secondary_id>
                <sec_id>CAAE-0005.0.342.000-10</sec_id>
                <issuing_authority>CONEP</issuing_authority>
            </secondary_id>
            
            <secondary_id>
                <sec_id>2010/05</sec_id>
                <issuing_authority>CEP39</issuing_authority>
            </secondary_id>
            
        </secondary_ids>

        <references>
            <link url="http://www.ensaiosclinicos.gov.br/rg/RBR-8mx5g6/v1/"></link>
        </references>

        
        
        <translation lang="es">
            <public_title></public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title></scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
            <hc_freetext></hc_freetext>
            <i_freetext></i_freetext>
            <inclusion_criteria></inclusion_criteria>
            <exclusion_criteria></exclusion_criteria>
            <study_design></study_design>
        </translation>
        
        <translation lang="pt-br">
            <public_title>Influência do uso do medicamento captopril na resposta da pressão arterial medida após uma sessão de exercício de musculação em homens com pressão alta</public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Efeito do captopril na resposta da pressão arterial após uma sessão de exercício resistido em homens hipertensos
</scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
            <hc_freetext>Hipertensão</hc_freetext>
            <i_freetext>Grupos: normotensos e hipertensos
Normotensos - avaliados sem terapia.
Hipertensos: Duas terapias orais 
diferentes, administradas por 4 semanas em ordem aleatória e duplo-cega. Terapias: Captopril (50 ou 75 mg, 3 vezes ao dia) e Placebo (3 cp/dia)
</i_freetext>
            <inclusion_criteria>Homens
Idade entre 30 a 60 anos
Não fumantes
Fisicamente inativos (não pratiquem atividades física regular mais de 2 vezes por semana)
Normotensos e hipertensos formarão 2 grupos específicos
Os hipertensos não deverão apresentar lesão de órgão alvo nem causa secundária de hipertensão, conforme rotina de avaliação da Liga de Hipertensão do Hospital das Clínicas da Faculdade de Medicina da USP. </inclusion_criteria>
            <exclusion_criteria>Indivíduos com obesidade (índice de massa corporal maior ou igual a 30kg/m2)
Indivíduos com diabetes (glicemia de jejum maior ou igual a 126 mg/dl)
Indivíduos com doenças cardíacas (diagnóstico prévio ou alteração no ECG de repouso ou exercício)
Indivíduos com intolerância à droga do estudo</exclusion_criteria>
            <study_design>Ensaio clínico, de fase 4, randomizado, controlado, duplo-cego, com 2 braço.</study_design>
        </translation>
        
        
    </trial>
    
</trials>


