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Central Hemodynamic Exercise Responses Study (CHeER)

26 de outubro de 2017 atualizado por: Arizona State University

Postexercise Central Blood Pressure and Hemodynamic Response After Continuous and Aerobic Interval Exercise

The purpose of this study is to examine the acute effect of continuous and aerobic interval exercise on postexercise central BP response in men with an elevated blood pressure.

Visão geral do estudo

Descrição detalhada

The specific aim of this study is to compare postexercise central blood pressure after continuous and aerobic interval exercise. It is hypothesized that aerobic interval exercise will produce a longer duration postexercise hypotensive response compared to continuous exercise. 14 healthy, inactive (defined as less than 60 minutes of moderate to vigorous physical activity per week, as characterized by accelerometry) men aged 18-45 yr, who have high normal BP or stage 1 hypertension (systolic BP (SBP) 120-159 mmHg or diastolic BP (DBP) 80-99 mmHg) according to JNC 8 established guidelines, will be included in this randomized cross-over design study. Each subject will complete three conditions in a randomized order: aerobic interval exercise, continuous exercise, and non-exercise control.

For the aerobic interval exercise condition, subjects will be equipped with a heart rate (HR) monitor and asked to perform an interval exercise bout on a cycle ergometer. To warm up, subjects will cycle at a work rate associated with 50% HRmax for 10 minutes. Wattage will then increase and subjects will do four 4-minute intervals at a work rate associated with 90%-95% HRmax, separated by 3 minutes of active recovery at a work rate associated with 50% HRmax. Subjects will be given a 5-minute cool-down period at a work rate associated with 50% HRmax. After the exercise, subjects will remain in the lab for 4 hours and their blood pressure will be measured every 10 minutes using the Oscar 2 with SphygmoCor ambulatory blood pressure system, and cardiac output measured in 10-second averages using the PhysioFlow. During this time, subjects will remain seated with their body posture maintained constant.

For the continuous exercise condition, subjects will be equipped with a HR monitor and asked to perform a continuous exercise bout on a cycle ergometer. To warm up, subjects will cycle at a work rate associated with 50% HRmax for 10 minutes. Wattage will then increase and subjects will perform a 30-minute exercise bout at a HR that elicits 75%-80% of their measured HRmax. Work rate will be adjusted, if needed, to keep HR within this value. Subjects will be given a 5-minute cool-down period at a work rate associated with 50% HRmax. After the exercise, subjects will remain in the lab for 4 hours and their blood pressure will be measured every 10 minutes using the Oscar 2 with SphygmoCor ambulatory blood pressure system, and cardiac output measured in 10-second averages using the PhysioFlow. During this time, subjects will remain seated with their body posture maintained constant.

For the non-exercise control condition, subjects will be asked to come to the laboratory for 4 hours and have their blood pressure will be measured every 10 minutes using the Oscar 2 with SphygmoCor ambulatory blood pressure system, and cardiac output measured in 10-second averages using the PhysioFlow. During this time, subjects will remain seated with their body posture maintained constant.

Tipo de estudo

Intervencional

Inscrição (Real)

5

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85004
        • Arizona State University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Macho

Descrição

Inclusion Criteria:

  • Inactive (defined as less than 60 minutes of moderate to vigorous physical activity per week, as characterized by accelerometry) non-smoking men who have high normal blood pressure or stage 1 hypertension (systolic BP (SBP) 120-159 mmHg or diastolic BP (DBP) 80-99 mmHg) according to JNC 8 established guidelines

Exclusion Criteria:

  • Men over 45 years old, who register more than 60 minutes/week of moderate-to-vigorous physical activity, or have a blood pressure less than 120/80 mmHg will be excluded. Those who answer positively (i.e., yes) on The Physical Activity Readiness Questionnaire (PAR-Q) will be excluded from participating in the study. Those with known cardiovascular, pulmonary, renal or metabolic disease, or having symptoms suggestive of these diseases will be excluded from the study as per current American College of Sports Medicine guidelines. Current smokers or anyone with contraindications to vigorous exercise will be excluded from the study as well. Subjects on medications used for the treatment of symptomatic cardiovascular disease will be excluded

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Triagem
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Non-exercise Control
Subjects will come to the laboratory for 4 hours and their blood pressure will be measured every 10 minutes using the Oscar 2 with SphygmoCor ambulatory blood pressure system, and cardiac output will be measured with 10-second averages using the PhysioFlow. During this time, subjects will remain seated with their body posture maintained constant
Experimental: Aerobic Interval Exercise
Subjects will be equipped with a heart rate (HR) monitor and perform an interval exercise bout on a cycle ergometer. To warm up, subjects will cycle at a work rate associated with 50% HRmax for 10 minutes. Wattage will then increase and subjects will do four 4-minute intervals at a work rate associated with 90%-95% HRmax, separated by 3 minutes of active recovery at a work rate associated with 50% HRmax. Subjects will be given a 5-minute cool-down period at a work rate associated with 50% HRmax. After the exercise, subjects will remain seated in the lab for 4 hours and their blood pressure will be measured every 10 minutes using the Oscar 2 with SphygmoCor ambulatory blood pressure system, and cardiac output will be measured with 10-second averages using the PhysioFlow.
Subjects will perform an interval exercise bout on a cycle ergometer. To warm up, they will cycle at a work rate associated with 50% of their max heart rate (HR) for 10 minutes. Wattage will then increase and they will do four 4-minute intervals at a work rate associated with 90%-95% HRmax, separated by 3 minutes of active recovery at a work rate associated with 50% HRmax They will be given a 5-minute cool-down period at a work rate associated with 50% of their max HR. After the exercise, they will remain in the lab for 4 hours and their blood pressure will be measured every 10 minutes using an automated blood pressure monitor and cardiac output will be measured using the PhysioFlow. They will remain seated during this time
Experimental: Continuous Exercise
Subjects will be equipped with a heart rate (HR) monitor and perform an interval exercise bout on a cycle ergometer. To warm up, subjects will cycle at a work rate associated with 50% HRmax for 10 minutes. Wattage will then increase and subjects will perform a 30-minute exercise bout at a HR that elicits 75%-80% of their measured HRmax. Work rate will be adjusted, if needed, to keep HR within this value. Subjects will be given a 5-minute cool-down period at a work rate associated with 50% HRmax. After the exercise, subjects will remain seated in the lab for 4 hours and their blood pressure will be measured every 10 minutes using the Oscar 2 with SphygmoCor ambulatory blood pressure system, and cardiac output will be measured with 10-second averages using the PhysioFlow.
Subjects will perform a 30-minute continuous exercise bout on a cycle ergometer. To warm up, they will cycle at a work rate associated with 50% of their max heart rate (HR) for 10 minutes. Wattage will then increase and they will perform a 30-minute exercise bout at a work rate associated with 75%-80% of their max HR. They will be given a 5-minute cool-down period at a work rate associated with 50% of their max HR. After the exercise, they will remain in the lab for 4 hours and their blood pressure will be measured every 10 minutes using an automated blood pressure monitor and cardiac output will be measured using the PhysioFlow. They will remain seated during this time.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Postexercise central blood pressure response after aerobic interval and continuous exercise
Prazo: 4 hours
After the subject performs both an aerobic interval and continuous exercise, blood pressure will be measured every 10-minutes using an ambulatory blood pressure monitor
4 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Postexercise hemodynamic response after aerobic interval and continuous exercise
Prazo: 4 hours
After the subject performs both an aerobic interval and continuous exercise, cardiac output will be measured in 10-second averages using the PhysioFlow
4 hours

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de março de 2017

Conclusão Primária (Antecipado)

1 de dezembro de 2017

Conclusão do estudo (Antecipado)

1 de dezembro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

13 de abril de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de abril de 2017

Primeira postagem (Real)

18 de abril de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de outubro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de outubro de 2017

Última verificação

1 de outubro de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • CHeER

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Aerobic Interval Exercise

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