- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03064256
Aerobic Physical Training and Heart Rate Variability in Hypertersion
EFFECT OF AEROBIC PHYSICAL TRAINING WITH DETERMINED INTENSITY FOR THE PROTOCOL OF DOUBLE EXHAUSTIVE EFFORTS IN THE AUTONOMICAL MODULATION OF THE HEART FREQUENCY OF PATIENTS WITH SYSTEMIC ARTERIAL HYPERTENSION
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The study was designed to compare changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the DENE protocol with that of patients who received routine ambulatory care 12 weeks after entering the study.
Sixty-three hypertensive men and women, divided into the intervention group (GI) (n=42) and the control group (n = 21) participated in the study.
All procedures were performed by trained researchers and qualified staff and the evaluations and intervention were performed at the specialty medical outpatient clinic.
After agreeing to participate in the study, we collected sociodemographic and clinical data, body mass index (BMI), waist circumference (WC) and waist / hip ratio (WHR). The participants were submitted to the cardiopulmonary exercise test (TECP), to evaluate the peak oxygen consumption (VO2peak), oxygen pulse and double product. Between one and seven days after TECP, consecutive heart rate intervals (iRR) were recorded for evaluation of autonomic heart rate modulation using a Polar model RS800CX (Polar Electro Co.Ltda Kempele, Finland). . The DENE protocol for determining the intensity of the training was applied in the GI to determine the training intensity in the treadmill. Intervention participants underwent supervised aerobic physical training at the pre-determined intensity, which consisted of three weekly sessions, lasting one hour, over a period of 12 weeks. Control participants receive routine care from the outpatient clinic for the same period. At the end of the 12 weeks, measures, recording of the iRR intervals, oxygen pulse, double product, BMI, waist circumference (AC), hip circumference (QC) and waist / hip ratio (WHR) were obtained. All subjects were previously informed about the procedures Signed a free and informed consent form. The project was approved by the Commission of Research Committee of the Institution with the number 086.096 / 14.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- SBP ≤ 180 mmHg and DBP ≤ 110 mmHg)
- low risk for physical training.
Exclusion Criteria:
- obesity III
- musculoskeletal conditions
- peripheral neuropathy
- Parkinson's disease.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Physical training program
Intervention participants are submitted to supervised aerobic physical training at the predetermined intensity, which is composed of three weekly sessions, lasting one hour, over a period of 12 weeks. All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise. |
Physical training program consisted of three weekly sessions lasting up to one hour over a period of twelve weeks.
and will be carried out respecting the traditional training principles: biological individuality, Specificity, overload, adaptation and reversibility
All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit).
The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.
|
|
Sem intervenção: Control Group
Control participants receive routine outpatient care for a 12-week period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Heart rate variability will be measured by nonlinear methods in hypertensive patients to observe changes in baseline values after 12 weeks.
Prazo: Finalized study (12 weeks)
|
A heart rate meter RS800CX (Polar Electro Co.Ltda.
Kempele, Finland) is used to obtain HR and R-R (iR-R) intervals.
The iR-Rs are captured from a tape with a coded transmitter placed in the chest region at the 5th intercostal space and transmitted to the cardiofrequency meter where they are recorded
|
Finalized study (12 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The peak oxygen consumption (mL / kg · min) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Prazo: Finalized study (12 weeks)
|
Cardiopulmonary exercise test used to determine peak oxygen consumption to exercise .
|
Finalized study (12 weeks)
|
|
The double product (mmHg) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Prazo: Finalized study (12 weeks)
|
Cardiopulmonary exercise test used to determine double produc to exercise .
|
Finalized study (12 weeks)
|
|
The oxigen pulse (ml/heart rate) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Prazo: Finalized study (12 weeks)
|
Cardiopulmonary exercise test used to determine oxigen pulse to exercise .
|
Finalized study (12 weeks)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 865.096
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
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 .