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- Ensaio Clínico NCT04821518
The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance as the Secondary Prevention in Patients After Brain Stroke
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Poznań, Polônia, 61-545
- Department of Rehabilitation and Physiotherapy Rehabilitation,
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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
The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom ischaemic stroke occurred within 14 days before the admission to the Clinical Department.
The control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from the hospital staff who did not experience stroke.
Descrição
Inclusion criteria to the post-stroke group were as follows :
- occurrence of hemiparesis after the first episode of ischaemic stroke
- stroke confirmed in the diagnostic imaging records
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score above 15 in Barthel's scale of performance in activities of daily living
- score below 12 in the National Institutes of Health Stroke Scale (NIHSS)
- available complete medical records concerning the assessed risk factors of recurrent CVD event
- lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma
Exclusion criteria from the post-stroke group were as follows:
- hemiparesis or tetraparesis following many episodes of stroke,
- lack of diagnostic imaging scans confirming the occurrence of stroke
- hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke
- incomplete medical records concerning the assessed risk factors of recurrent CVD event
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score below 14 in Barthel's scale of performance in activities of daily living
- score above 13 in the NIHSS scale
- occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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The study group (post-stroke)
The study group consisted of 26 patients in whom ischaemic brain stroke occurred within 14 days before the admission to the Clinical Department, and were hospitalised at the Department of Neurological Rehabilitation of the Clinical Department of Rehabilitation in the Wiktor Dega Orthopaedic and Rehabilitation Clinical Hospital in Poznań
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The control group
The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke.
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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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heart rate at rest
Prazo: baseline
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heart rate per minute
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baseline
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heart rate at rest
Prazo: 3 weeks
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heart rate per minute
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3 weeks
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heart rate after SMWT
Prazo: baseline
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heart rate per minute
|
baseline
|
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heart rate after SMWT
Prazo: 3 weeks
|
heart rate per minute
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3 weeks
|
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heart rate after SCT
Prazo: baseline
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heart rate per minute
|
baseline
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heart rate after SCT
Prazo: 3 weeks
|
heart rate per minute
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3 weeks
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heart rhythm at rest
Prazo: baseline
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heart rhythm interpreting ECG (regular or irregular)
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baseline
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heart rhythm at rest
Prazo: 3 weeks
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heart rhythm interpreting ECG (regular or irregular)
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3 weeks
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heart rhythm after SMWT
Prazo: baseline
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heart rhythm interpreting ECG (regular or irregular)
|
baseline
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heart rhythm after SMWT
Prazo: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
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heart rhythm after SCT
Prazo: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
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heart rhythm after SCT
Prazo: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
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3 weeks
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increased blood pressure at rest
Prazo: baseline
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blood pressure value [mm/Hg]
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baseline
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increased blood pressure at rest
Prazo: 3 weeks
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blood pressure value [mm/Hg]
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3 weeks
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increased blood pressure after SMWT
Prazo: baseline
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blood pressure value [mm/Hg]
|
baseline
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increased blood pressure after SMWT
Prazo: 3 weeks
|
blood pressure value [mm/Hg]
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3 weeks
|
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increased blood pressure after SCT
Prazo: baseline
|
blood pressure value [mm/Hg]
|
baseline
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increased blood pressure after SCT
Prazo: 3 weeks
|
blood pressure value [mm/Hg]
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3 weeks
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Distance of walk after SMWT
Prazo: baseline
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Distance (metres)
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baseline
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Distance of walk after SMWT
Prazo: 3 weeks
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Distance (metres)
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3 weeks
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Distance of walk after SCT
Prazo: baseline
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Distance (metres)
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baseline
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Distance of walk after SCT
Prazo: 3 weeks
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Distance (metres)
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3 weeks
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Steps after SMWT
Prazo: baseline
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Number of steps (number)
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baseline
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Steps after SMWT
Prazo: 3 weeks
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Number of steps (number)
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3 weeks
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Steps after SCT
Prazo: baseline
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Number of steps (number)
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baseline
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Steps after SCT
Prazo: 3 weeks
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Number of steps (number)
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3 weeks
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Velocity of walk after SMWT
Prazo: baseline
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Mean velocity (km/h)
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baseline
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Velocity of walk after SMWT
Prazo: 3 weeks
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Mean velocity (km/h)
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3 weeks
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Velocity of walk after SCT
Prazo: baseline
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Mean velocity (km/h)
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baseline
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Velocity of walk after SCT
Prazo: 3 weeks
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Mean velocity (km/h)
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3 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań
Publicações e links úteis
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
- 1/2021
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