- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03093623
O efeito da atividade física e da abstinência de fumo na lesão pré-cancerosa
O Efeito da Atividade Física e Abster-se de Fumar na Regressão de Lesões Pré-Cancerosas.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Taipei, Taiwan, 110
- Recrutamento
- Taipei Medical University
-
Contato:
- Wen-Chi Liu, MSc
- Número de telefone: 1300 02-227372181
- E-mail: 116085@tmuh.org.tw
-
Investigador principal:
- Hsiu-Ting Tsai, Phd
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Critério de inclusão:
- Pacientes com neoplasia pré-cancerosa
- entre 20 a 70 anos
Critério de exclusão:
- Pacientes com doença cardíaca do servidor ou outro tipo de câncer.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: PREVENÇÃO
- Alocação: RANDOMIZADO
- Modelo Intervencional: CROSSOVER
- Mascaramento: SOLTEIRO
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
EXPERIMENTAL: Atividade física
No grupo experimental de atividade física, enfermeiras treinadas entrevistarão os pacientes, darão educação em saúde, ensinarão como usar e registrar o medidor de atividade. Os profissionais calcularão o Equivalente Metabólico da Tarefa (MET) com a fórmula semanalmente. MET = (nível de intensidade 9 pontos * tempo de cada exercício (horas) * número de vezes por semana + nível moderado 5 pontos * tempo por atividade (horas) * número de vezes por semana + nível baixo 3 pontos * tempo por atividade (horas) * número de vezes por semana) ,os investigadores esperam que os pacientes no primeiro mês MET possam atingir (3,75-7,49
MET-h/semana) e atinge atividade moderada ou mais que moderada (>= 7,5-16,49
MET-h/semana) no início do segundo mês por pelo menos um ano.
|
No grupo experimental de atividade física, enfermeiras treinadas entrevistarão os pacientes, darão educação em saúde, ensinarão como usar e registrar o medidor de atividade. Os profissionais calcularão o Equivalente Metabólico da Tarefa (MET) com a fórmula semanalmente. MET = (nível de intensidade 9 pontos * tempo de cada exercício (horas) * número de vezes por semana + nível moderado 5 pontos * tempo por atividade (horas) * número de vezes por semana + nível baixo 3 pontos * tempo por atividade (horas) * número de vezes por semana) ,os investigadores esperam que os pacientes no primeiro mês MET possam atingir (3,75-7,49
MET-h/semana) e atinge atividade moderada ou mais que moderada (>= 7,5-16,49
MET-h/semana) no início do segundo mês por pelo menos um ano.
|
|
SEM_INTERVENÇÃO: Atividade não física
o grupo sem atividade física, os investigadores não lhes dão nenhuma intervenção física
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
O efeito da atividade física e da abstinência de fumo na regressão de tumores pré-cancerosos
Prazo: 2 anos
|
Estimar o efeito da atividade física moderada e abster-se de fumar pode fortalecer o sistema imunológico inato, o sistema imunológico humano adaptativo e pode ajudar na regressão da neoplasia intraepitelial cervical entre pacientes com câncer cervical. Usando uma medida de resultado composto que consiste em questionário, hemograma, plasma e DNA. hemogramas: glóbulos brancos, hemoglobina, glóbulos vermelhos, plaquetas, neutrófilos, linfócitos, monócitos, eosinófilos, basófilos, CD-4, CD-8, células NK, células B. plasma: lL-1,IL-2,IL-4,IL-5,IL,6,LI-8,IL-10,IL-13,TNF-r |
2 anos
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hsiu-Ting Tsai, Phd, Taipei Medical University
Publicações e links úteis
Publicações Gerais
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- Ishikawa S, Suga H, Fukushima M, Yoshida A, Yoshida Y, Sunagawa M, Hisamitsu T. Blood fluidity enhancement by electrical acupuncture stimulation is related to an adrenergic mechanism. J Acupunct Meridian Stud. 2012 Feb;5(1):21-8. doi: 10.1016/j.jams.2011.11.003. Epub 2011 Dec 17.
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Datas de registro do estudo
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Conclusão do estudo (ANTECIPADO)
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- TMU-JIRB:201410013
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