EENM em pacientes com IC para melhorar a recuperação funcional após a hospitalização (NeuHFRecover)
Estimulação elétrica neuromuscular em pacientes com insuficiência cardíaca para melhorar a recuperação funcional após a hospitalização (NeuHF-Recover)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Vermont
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Burlington, Vermont, Estados Unidos, 05405
- University of Vermont Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Critério de inclusão:
- 50-90 anos de idade
- diagnóstico clínico de ICFEP sendo controlado ativamente durante a hospitalização
- viver dentro de 30 milhas do centro médico
- capaz de realizar o consentimento informado
Critério de exclusão:
- artrite reumatoide ou outra doença inflamatória/autoimune
- câncer, excluindo câncer de pele não melanoma ou câncer de próstata de baixo grau
- demência grave/doença de alzheimer
- doença vascular periférica limitante do exercício
- doença neuromuscular ou disfunção neuromuscular associada a evento cerebrovascular
- índice de massa corporal ≥40 kg/m2
- coágulo de sangue em membros inferiores ou cardioversor-desfibrilador implantável ou marca-passo
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Estimulação elétrica neuromuscular
Estimulação elétrica neuromuscular do quadríceps.
45 minutos, 5 dias por semana
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Estimulação bilateral do músculo quadríceps
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Sem intervenção: Ao controle
Sem controle de tratamento
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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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Distância de caminhada de 6 minutos (6MW)
Prazo: Alteração da alta hospitalar (dentro de 1 dia) para 4 semanas após a alta
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6 MW foi desenvolvido para avaliar a aptidão cardiopulmonar em pacientes com doenças pulmonares e cardíacas e foi validado em pacientes com insuficiência cardíaca.
Ele avalia a distância que um paciente pode caminhar em 6 minutos em um percurso padrão.
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Alteração da alta hospitalar (dentro de 1 dia) para 4 semanas após a alta
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Bateria de Desempenho Físico Curto
Prazo: Alteração da alta hospitalar (dentro de 1 dia) para 4 semanas após a alta
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A Short Physical Performance Battery é composta por três tarefas que avaliam o equilíbrio, a velocidade da marcha e a capacidade de se levantar de uma cadeira.
As unidades em uma escala para cada domínio variam de 0 a 4 para uma pontuação total de 0 a 12, com uma pontuação mais alta indicando melhor função física.
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Alteração da alta hospitalar (dentro de 1 dia) para 4 semanas após a alta
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Formulário Resumido de Resultados Médicos 36
Prazo: Alta hospitalar (dentro de 1 dia) e 4 semanas após a alta
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O Medical Outcomes Short Form 36 é um questionário que avalia a saúde autorrelatada e o estado funcional físico.
Existem 36 perguntas que refletem oito subdomínios de saúde incluídos neste questionário.
As pontuações para cada domínio representam somas ponderadas das questões em cada subdomínio.
Cada escala é transformada diretamente em uma escala de 0 a 100, na suposição de que cada questão tem o mesmo peso.
Essa medida representa a pontuação total computada em todos os subdomínios.
Pontuações mais baixas representam pior saúde geral, enquanto pontuações mais altas representam melhor saúde.
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Alta hospitalar (dentro de 1 dia) e 4 semanas após a alta
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Índice de Katz de Independência em Atividades da Vida Diária
Prazo: Alta hospitalar (dentro de 1 dia) e 4 semanas após a alta
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O Índice de Katz de Independência nas Atividades de Vida Diária, comumente referido como AVD de Katz, é o instrumento mais adequado para avaliar o estado funcional como uma medida da capacidade do cliente de realizar atividades de vida diária de forma independente.
Os médicos normalmente usam a ferramenta para detectar problemas na realização de atividades da vida diária e planejar os cuidados de acordo.
O Índice classifica a adequação do desempenho nas seis funções de tomar banho, vestir-se, ir ao banheiro, transferir, continência e alimentação.
Os clientes recebem pontuação sim/não para independência em cada uma das seis funções.
Uma pontuação de 6 indica função completa, 4 indica comprometimento moderado e 2 ou menos indica comprometimento funcional grave.
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Alta hospitalar (dentro de 1 dia) e 4 semanas após a alta
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Lawton Instrumental Activities of Daily Living (IADL) Scale
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering have been excluded. Since men regularly complete food preparation, housekeeping, and laundering tasks, they were scored in all 8 domains as well. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and men. |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 1
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q1.
In general, would you say your health is:
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 2
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q2.
Compared to one year ago, how would you rate your health in general now?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3a
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3a.
Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3b
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3b.
Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3c
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3c.
Lifting or carrying groceries.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3d
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3d.
Climbing several flights ofstairs
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3e
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3e.
Climbing one flight of stairs
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3f
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3f.
Bending, kneeling, or stooping
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3g
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3g.
Walking more than a mile
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3h
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3h.
Walking several blocks
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3i
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3i.
Walking one block
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3j
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3j.
Bathing or dressing yourself
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4a
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4a.
Cut down the amount of time you spent on work or other activities
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4b
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4b.
Accomplished less than you would like
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4c
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4c.
Were limited in the kind of work or other activities
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4d
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4d.
Had difficulty performing the work or other activities (for example, it took extra effort)
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5a
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5a.
Cut down the amount of time you spent on work or other activities
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5b
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5b.
Accomplished less than you would like
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5c
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5c.
Didn't do work or other activities as carefully as usual
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 6
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q6.
During the past 4weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 7
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q7.
How much bodily pain have you had during the past four weeks?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 8
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q8.
During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9a
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9a. Did you feel full of pep? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9b
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9b. Have you been a very nervous person? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9c
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9c. Have you felt so down in the dumps that nothing could cheer you up? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9d
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9d. Have you felt calm and peaceful? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9e
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9e. Did you have a lot of energy? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9f
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9f. Have you felt down hearted and blue? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9g
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9g. Did you feel worn out? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9h
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9h. Have you been a happy person? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9i
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9i. Did you feel tired? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9j
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9j. During the past 4weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10a
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10a. I seem to get sick a little easier than other people |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10b
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10b. I am as healthy as anybody I know |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10c
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10c. I expect my health to get worse |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10d
Prazo: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10d. My health is excellent |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00001757
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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