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- Ensaio Clínico NCT03531034
Ambulatory and Blood Pressure Variability Responses to Exercise in Normotensive and Hypertensive Women
7 de janeiro de 2021 atualizado por: Igor Moraes Mariano, Federal University of Uberlandia
Ambulatory and Blood Pressure Variability Responses to Combined Exercise in Normotensive and Hypertensive Menopausal Women
This study evaluated the differences between normotensive and hypertensive menopausal women in ambulatory and blood pressure variability responses to combined aerobic and resistance exercise.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The differences in hypotensive and cardioprotective responses of exercise among menopausal hypertensive and normotensive women are still not very clear, mainly the responses of blood pressure variability.
In this way, were evaluated 6 indices related to the variability of 24 hour ambulatory pressure measurements in these women before and after 12 weeks of combined exercise training.
Tipo de estudo
Intervencional
Inscrição (Real)
26
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
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Minas Gerais
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Uberlandia, Minas Gerais, Brasil, 38400-678
- Guilherme Morais Puga
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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
50 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- amenorrhea for at least 12 months; body mass index ≤30 kg/m2; ability to engage in treadmill and resistance exercises; hypertension nom-medicated with beta-blockers
Exclusion Criteria:
- history of diabetes, cancer or cardiovascular disease (except for hypertension in Hypertensive group); doing hormone therapy or soy derived supplementation; smokers
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: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Hypertensive Women
Group of hypertensive and controlled women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities.
In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months
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The program consisted of 30 sessions of combined aerobic and resistance exercises training during 10 consecutive weeks.
Each session lasted 45 minutes and consisted of 5 minutes warm-up, 20 minutes of resistance exercise and 20 minutes of aerobic exercise.
The resistance training was performed in two sets of 15 repetitions in seven exercises of weight training (Based on 1 repetition maximum test - 1RM) for large muscle groups.
The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between ventilatory threshold 1 and 2 intensities.
After 5 weeks of training, 1RM test was performed again to readjust the resistance load and aerobic intensity was readjusted by heart rate predicted in the incremental test.
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Comparador Ativo: Normotensive Women
Group of normotensive women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities.
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The program consisted of 30 sessions of combined aerobic and resistance exercises training during 10 consecutive weeks.
Each session lasted 45 minutes and consisted of 5 minutes warm-up, 20 minutes of resistance exercise and 20 minutes of aerobic exercise.
The resistance training was performed in two sets of 15 repetitions in seven exercises of weight training (Based on 1 repetition maximum test - 1RM) for large muscle groups.
The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between ventilatory threshold 1 and 2 intensities.
After 5 weeks of training, 1RM test was performed again to readjust the resistance load and aerobic intensity was readjusted by heart rate predicted in the incremental test.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in Ambulatorial Blood Pressure
Prazo: Before and within 72 hours after 10 weeks of exercise training
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All volunteers were submitted to a 24-hour Blood Pressure (BP) assessment by Ambulatorial Blood Pressure Monitoring (ABPM) before and after 10 weeks of combined exercise training, with a minimum of 48 hours after the last training session.
A device was used associated with a diary of examination to self-report of activities of daily living (sleep, work, food) or any event that could interfere abnormally with BP or device measurements.
The device was always placed 7am and the measurements were made every 15 minutes from 7h to 23h and every 30 minutes from 23h to 7h.
The monitoring was considered valid when it happened for a period of 24 hours.
The following results were evaluated: systolic blood pressure; diastolic blood pressure, mean blood pressure and heart rate in awake, sleep and 24-hour periods.
Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position.
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Before and within 72 hours after 10 weeks of exercise training
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in Ambulatorial Blood Pressure Variability
Prazo: Before and within 72 hours after 10 weeks of exercise training
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Based on Ambulatorial Blood Pressure data, were calculated Blood Pressure Variability by: 24-hour standard deviation weighted by the time interval between consecutive readings; the mean diurnal and nocturnal deviations weighted for the duration of the daytime and nighttime interval; the average real variability weighted for the time interval between consecutive readings; the ambulatory arterial stiffness index calculated by the slope of the trend curve of the dispersion of pressure data; the morning surge that represents the dynamic daytime variation in morning pressure that tends to increase, being assessed from the point of least pressure during sleep in relation to the first two hours after waking; and nocturnal dipping, that represents the average percentage drop of sleep pressure in relation to wakefulness, and individuals with falls of 10% or more are considered dippers and below that are considered nom-dippers.
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Before and within 72 hours after 10 weeks of exercise training
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Changes in Heart Rate Variability
Prazo: Before and within 72 hours after 10 weeks of exercise training
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Heart Rate (HR) was recorded using a heart rate monitor in a beat-by-beat basis.
HR was registered in a seat position for 20 min of rest.
Prior to the HR Variability (HRV) analysis, the RR intervals (RRi) were visually inspected and filtered using a moving average filter.
The HRV was analyzed in both time-, frequency- and nonlinear-domain.
Being that for frequency-domain analysis, firstly the RRi series were interpolated at 4 Hz and then the signal linear trend component removal was performed using the smooth priors approach.
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Before and within 72 hours after 10 weeks of exercise training
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Changes in salivary oxidative stress
Prazo: Before and within 72 hours after 10 weeks of exercise training
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The salivary was collected after 12-hours fasting and the total antioxidant capacity was evaluated using the Ferric-Ability of Plasma (FRAP) methodology and calculated from the standard trolox curve.
The activity of the enzyme superoxide dismutase (SOD) was determined based on the auto oxidation capacity of pyrogallol and catalase activity (CAT) by monitoring the consumption of hydrogen peroxide at 240 nm.
Lipid peroxidation levels were determined by the TBARS method (thiobarbituric acid reactive substances), using as standard a curve of 1,1,3,3-tetraethoxypropane (TMP).
The total protein concentration was obtained by the Bradford method (BRADFORD, 1976), using bovine serum albumin (BSA) as standard.
The amounts of nitric oxide (NO) were estimated by the determination of total nitrite by the Griess colorimetric method.
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Before and within 72 hours after 10 weeks of exercise training
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Guilherme M Puga, Dr, Federal University of Uberlândia
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)
1 de março de 2014
Conclusão Primária (Real)
25 de dezembro de 2015
Conclusão do estudo (Real)
25 de dezembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
17 de abril de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de maio de 2018
Primeira postagem (Real)
21 de maio de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de janeiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 40622414.9.0000.5152
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
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