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- Ensaio Clínico NCT04812600
Microfluidic-based Tactile Sensor in Cardiac Rehabilitation
Microfluidic-based Tactile Sensor for Arterial Pulse Signal Measurements in Patients Going Through Cardiac Rehabilitation
Visão geral do estudo
Status
Descrição detalhada
The investigators will make the following research measurements (pre-exercise measurement and post-exercise measurement) on the first day of cardiac rehab, and following 1 and 4 weeks of cardiac rehabilitation.
Subjects will have their arterial pulse measured at the radial (wrist), carotid (neck) and temple (side of the head) arteries. The sensor will remain in place for 2-3 minutes while the recordings are made. Light pressure will be applied during this time. Blood pressure will also be obtained in the opposite arm.
The subject will then exercise on the modalities, intensity and duration designated by the staff in the Sentara Heart Hospital Cardiac Rehabilitation. It's important to note, that the normal standard of care will not change by the individual participating in this research study. The participants will follow standard physician ordered cardiac rehabilitation. The order of the modalities performed will be completed in the same order on the day of research testing in weeks 1 and 4.
After finishing the exercise, the subject will sit down for 1hr. The participant's pulse signals will be measured at 0-5min, 10min, 20 min, 30min and 1hr after exercise. Blood pressure will also be obtained from the opposite arm at the same time intervals.
The investigators will be collecting cardiac rehab data from each research day. This data will be entered into Redcap by the Sentara researchers.
The investigators will record from the most recent values/visits prior to start of cardiac rehab therapy, and this information will be entered into Redcap by the Sentara researchers.
The investigators will document at 1, 2 and 3 years from start of cardiac rehab, as to patient survival status.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Virginia
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Norfolk, Virginia, Estados Unidos, 23501
- Recrutamento
- Sentara Heart Hospital
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Contato:
- Jennifer May, Ph.D.
- Número de telefone: 757-388-1926
- E-mail: jlfreema@sentara.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age 45-70
- Subjects who qualify for cardiac rehabilitation via doctor's orders
Exclusion Criteria:
●Physical limitations which would preclude one from performing exercise.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Cardiac Rehabilitation
Individuals assigned to phase II (outpatient) cardiac rehabilitation program will undergo their normal exercise routines while the investigators make the measurements pre and post exercise at 0 week, and following 1 and 4 weeks of exercise.
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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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Micro-tactile sensor assessment of arterial stiffness change to exercise
Prazo: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Elasticity (unit measure: pascal) of arterial wall will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Micro-tactile sensor assessment of arterial viscosity change to exercise
Prazo: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Damping (unit measure: pascal x sec) of the arterial wall will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Micro-tactile sensor assessment of arterial radius change to exercise
Prazo: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Size of the artery lumen (unit measure: mm) will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise
Prazo: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Systolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Julie Hao, Ph.D., Old Dominion University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 19-04-FB-0100
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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