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- Ensaio Clínico NCT04871906
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
29 de abril de 2021 atualizado por: Mei-Wun Tsai, National Yang Ming University
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
Visão geral do estudo
Descrição detalhada
This study examines the relationship between circulations and walking speeds.
Most studies in the field of stretching exercises have only focused on improvements of endothelial functions in younger population; however, I aim to emphasize its effects on different populations, such as people with frailty, low physical activity level, weakness and postoperative status.
Previous research has established that stretching exercises can improve walking function by modulations of musculoskeletal or neuromuscular system.
The importance and originality of this study are that it explores the relationship between circulation and walking speed.
Due to the inability to extrapolate outcomes; short-term effect of improved blood vessel function; the unclear mechanism of stretching exercises; and considering the different physical fitness groups, I design a home-based, low-dose, and anatomic chain-based stretching exercises to verify the possible mechanism and effects.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
48
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.
Contato de estudo
- Nome: Mei-Wun Tsai, Ph.D
- Número de telefone: +886+2+28267939
- E-mail: tmwk@ym.edu.tw
Locais de estudo
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Taipei, Taiwan, 112
- Recrutamento
- National Yang Ming University
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Contato:
- Mei-Wun Tsai, Ph.D
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Contato:
- Liang-Ying Lai
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Investigador principal:
- Liang-Ying Lai
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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
20 anos a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- age between 20-85 years old
- Follow instructions
- Walk with/without assistive technology
Exclusion Criteria:
- Unstable acute or chronic health conditions
- Peripheral vascular diseases
- Non-musculoskeletal problems that would limit stretching exercises
- Participate in other exercise programs
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: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Stretching exercises
Interventions are home-based stretching exercises.
The experimental group will receive 6 stretching exercises which stretch 20-30 seconds, relax for 10 seconds, and repeat 5 times for each side.
It will take 25-30 minutes every day for continuous 8 weeks.
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Our interventions are home-based stretching exercises.
The experimental group will receive 6 stretching exercises which stretch 20-30 seconds, relax for 10 seconds, and repeat 5 times for each side.
It will take 25-30 minutes every day for continuous 8 weeks.
Those include stretching of the deep front line, spiral line, superficial front line, lateral line, superficial back line, and plantar flexors.
Designed concepts are the following three: 1) based on ''Anatomy- Train'' theory, 2) emphasize on movements of trunk and pelvis, and 3) stress on the stretching of lower extremities.
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Sem intervenção: Control group
Maintain their daily activity level in the 8 weeks.
We use the study desigh-''waiting list control'' in this group.
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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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vascular functions-Stiffness index(1)
Prazo: pre-intervention(1st week)
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(Stiffness index, SI,unit:m/s)
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pre-intervention(1st week)
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vascular functions-Stiffness index(2)
Prazo: during intervention(4th week)
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(Stiffness index, SI,unit:m/s)
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during intervention(4th week)
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vascular functions-Stiffness index(3)
Prazo: post-intervention(8th week)
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(Stiffness index, SI,unit:m/s)
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post-intervention(8th week)
|
|
vascular functions-Reflective index(1)
Prazo: pre-intervention(1st week)
|
(Reflective index, RI,unit:%)
|
pre-intervention(1st week)
|
|
vascular functions-Reflective index(2)
Prazo: during intervention(4th week)
|
(Reflective index, RI,unit:%)
|
during intervention(4th week)
|
|
vascular functions-Reflective index(3)
Prazo: post-intervention(8th week)
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(Reflective index, RI,unit:%)
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post-intervention(8th week)
|
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vascular functions-Vascular age
Prazo: pre-intervention(1st week)
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(Vascular age, VA,unit:year-old)
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pre-intervention(1st week)
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|
Ultrasound parameters-peak-systolic velocity(1)
Prazo: pre-intervention(1st week)
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(peak-systolic velocity, PSV)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-peak-systolic velocity(2)
Prazo: during intervention(4th week)
|
(peak-systolic velocity, PSV)
|
during intervention(4th week)
|
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Ultrasound parameters-peak-systolic velocity(3)
Prazo: post-intervention(8th week)
|
(peak-systolic velocity, PSV)
|
post-intervention(8th week)
|
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Ultrasound parameters-end-diastolic velocity(1)
Prazo: pre-intervention(1st week)
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(end-diastolic velocity, EDV)
|
pre-intervention(1st week)
|
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Ultrasound parameters-end-diastolic velocity(2)
Prazo: during intervention(4th week)
|
(end-diastolic velocity, EDV)
|
during intervention(4th week)
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Ultrasound parameters-end-diastolic velocity(3)
Prazo: post-intervention(8th week)
|
(end-diastolic velocity, EDV)
|
post-intervention(8th week)
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Ultrasound parameters-mean velocity(1)
Prazo: pre-intervention(1st week)
|
(mean velocity, mV)
|
pre-intervention(1st week)
|
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Ultrasound parameters-mean velocity(2)
Prazo: during intervention(4th week)
|
(mean velocity, mV)
|
during intervention(4th week)
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Ultrasound parameters-mean velocity(3)
Prazo: post-intervention(8th week)
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(mean velocity, mV)
|
post-intervention(8th week)
|
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Ultrasound parameters-mean volume flow(1)
Prazo: pre-intervention(1st week)
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(mean volume flow, vFl)
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pre-intervention(1st week)
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Ultrasound parameters-mean volume flow(2)
Prazo: during intervention(4th week)
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(mean volume flow, vFl)
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during intervention(4th week)
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Ultrasound parameters-mean volume flow(3)
Prazo: post-intervention(8th week)
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(mean volume flow, vFl)
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post-intervention(8th week)
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Ultrasound parameters-resistance index(1)
Prazo: pre-intervention(1st week)
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(resistance index, RI)
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pre-intervention(1st week)
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Ultrasound parameters-resistance index(2)
Prazo: during intervention(4th week)
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(resistance index, RI)
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during intervention(4th week)
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Ultrasound parameters-resistance index(3)
Prazo: post-intervention(8th week)
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(resistance index, RI)
|
post-intervention(8th week)
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Ultrasound parameters-pulsatility index(1)
Prazo: pre-intervention(1st week)
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(pulsatility index, PI)
|
pre-intervention(1st week)
|
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Ultrasound parameters-pulsatility index(2)
Prazo: during intervention(4th week)
|
(pulsatility index, PI)
|
during intervention(4th week)
|
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Ultrasound parameters-pulsatility index(3)
Prazo: post-intervention(8th week)
|
(pulsatility index, PI)
|
post-intervention(8th week)
|
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Ultrasound parameters-diameter(1)
Prazo: pre-intervention(1st week)
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(diameter, D)
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pre-intervention(1st week)
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Ultrasound parameters-diameter(2)
Prazo: during intervention(4th week)
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(diameter, D)
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during intervention(4th week)
|
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Ultrasound parameters-diameter(3)
Prazo: post-intervention(8th week)
|
(diameter, D)
|
post-intervention(8th week)
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Ultrasound parameters-area(1)
Prazo: pre-intervention(1st week)
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(area, A)
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pre-intervention(1st week)
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Ultrasound parameters-area(2)
Prazo: during intervention(4th week)
|
(area, A)
|
during intervention(4th week)
|
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Ultrasound parameters-area(3)
Prazo: post-intervention(8th week)
|
(area, A)
|
post-intervention(8th week)
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walking speed-preferred(1)
Prazo: pre-intervention(1st week)
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Timed 10-Meter Walk Test (preferred)
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pre-intervention(1st week)
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walking speed-preferred(2)
Prazo: during intervention(4th week)
|
Timed 10-Meter Walk Test (preferred)
|
during intervention(4th week)
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walking speed-preferred(3)
Prazo: post-intervention(8th week)
|
Timed 10-Meter Walk Test (preferred)
|
post-intervention(8th week)
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walking speed-fast(1)
Prazo: pre-intervention(1st week)
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Timed 10-Meter Walk Test (fast)
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pre-intervention(1st week)
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walking speed-fast(2)
Prazo: during intervention(4th week)
|
Timed 10-Meter Walk Test (fast)
|
during intervention(4th week)
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walking speed-fast(3)
Prazo: post-intervention(8th week)
|
Timed 10-Meter Walk Test (fast)
|
post-intervention(8th week)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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body composition-height
Prazo: pre-intervention(1st week)
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height(cm)
|
pre-intervention(1st week)
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body composition-weight
Prazo: pre-intervention(1st week)
|
weight(kg)
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pre-intervention(1st week)
|
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body composition-waist circumference
Prazo: pre-intervention(1st week)
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waist circumference(cm)
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pre-intervention(1st week)
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vital sign-blood pressure(1)
Prazo: pre-intervention(1st week)
|
blood pressure(mmHg)
|
pre-intervention(1st week)
|
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vital sign-blood pressure(2)
Prazo: during intervention(4th week)
|
blood pressure(mmHg)
|
during intervention(4th week)
|
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vital sign-blood pressure(3)
Prazo: post-intervention(8th week)
|
blood pressure(mmHg)
|
post-intervention(8th week)
|
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vital sign-heart rate(1)
Prazo: pre-intervention(1st week)
|
heart rate(bpm)
|
pre-intervention(1st week)
|
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vital sign-heart rate(2)
Prazo: during intervention(4th week)
|
heart rate(bpm)
|
during intervention(4th week)
|
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vital sign-heart rate(3)
Prazo: post-intervention(8th week)
|
heart rate(bpm)
|
post-intervention(8th week)
|
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flexibility-chair sit and reach test (1)
Prazo: pre-intervention(1st week)
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chair sit and reach test (cm)
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pre-intervention(1st week)
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flexibility-chair sit and reach test (2)
Prazo: during intervention(4th week)
|
chair sit and reach test (cm)
|
during intervention(4th week)
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flexibility-chair sit and reach test (3)
Prazo: post-intervention(8th week)
|
chair sit and reach test (cm)
|
post-intervention(8th week)
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grip strength
Prazo: pre-intervention(1st week)
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hand dynamometer
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pre-intervention(1st week)
|
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cognitive function
Prazo: pre-intervention(1st week)
|
Montreal Cognitive Assessment.Minimum value is 0 and maximum value is 30, and higher scores mean a better outcome
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pre-intervention(1st week)
|
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frailty
Prazo: pre-intervention(1st week)
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SOF (Study of Osteoporotic Fractures).
Minimum value is 0 and maximum value is 3, and higher scores mean a worse outcome
|
pre-intervention(1st week)
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basic data
Prazo: pre-intervention(1st week)
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gender, age, education, living status, smoking, and exercise habits
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pre-intervention(1st week)
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ACSM-PAR-Q+
Prazo: pre-intervention(1st week)
|
The Physical Activity Readiness Questionnaire for Everyone AND follow-up questions about their medical conditions (PAR-Q+) is used to identify whether subjects are at risk in engaging in exercises.
Thus, researchers can prescribe individual exercise prescriptions.
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pre-intervention(1st week)
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IPAQ
Prazo: pre-intervention(1st week)
|
International Physical Activity Questionnaire to investigate their physical activity levels.
Higher the amount of physical activity (min-METs/week) means a more active life-style(physical activity level).
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pre-intervention(1st week)
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fitness
Prazo: pre-intervention(1st week)
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(Duke activity status index, DASI) Minimum value is 0 and maximum value is 58.2, and higher scores mean a better physical activity level.
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pre-intervention(1st week)
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adherence of exercise
Prazo: post-intervention(8th week)
|
usage records from the Line app
|
post-intervention(8th week)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Liang-Ying Lai, National Yang Ming University
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 setembro de 2020
Conclusão Primária (Antecipado)
30 de junho de 2021
Conclusão do estudo (Antecipado)
30 de junho de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
26 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2021
Primeira postagem (Real)
4 de maio de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de maio de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- YM109100E
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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