NMES en pacientes con IC para mejorar la recuperación funcional tras la hospitalización (NeuHFRecover)
13 de mayo de 2026 actualizado por: Sherrie Khadanga, University of Vermont Medical Center
Estimulación eléctrica neuromuscular en pacientes con insuficiencia cardíaca para mejorar la recuperación funcional después de la hospitalización (NeuHF-Recover)
El objetivo de este estudio de investigación es comprender si un programa de ejercicios en el hogar iniciado después de la hospitalización por HFpEF y continuado durante 4 semanas después del alta hospitalaria puede preservar o mejorar la función física.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
La insuficiencia cardíaca es la principal causa de hospitalización entre los adultos en los EE. UU. y los pacientes con fracción de eyección preservada (HFpEF, por sus siglas en inglés) comprenden la mitad de esas admisiones.
Muchos pacientes presentan fatiga crónica, intolerancia al ejercicio e incapacidad para realizar las actividades de la vida diaria, lo que se ve agravado por la hospitalización.
El objetivo de este estudio de investigación es comprender si un programa de ejercicios en el hogar iniciado poco después de la hospitalización y continuado durante 4 semanas después del alta puede mejorar la recuperación funcional en pacientes con HFpEF.
Los voluntarios serán asignados aleatoriamente para recibir estimulación eléctrica neuromuscular (NMES) de sus músculos cuádriceps o para no recibir NMES (grupo de control).
Los voluntarios serán evaluados durante la hospitalización y 4 semanas después del alta.
Las evaluaciones incluirán mediciones de la función física mediante la prueba de caminata de 6 minutos y la batería de rendimiento físico breve, así como la evaluación de la capacidad funcional física subjetiva y la calidad de vida mediante el formulario corto de resultados médicos 36 y el cuestionario de cardiomiopatía de Kansas City.
Tipo de estudio
Intervencionista
Inscripción (Actual)
8
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Vermont
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Burlington, Vermont, Estados Unidos, 05405
- University of Vermont Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- 50-90 años de edad
- diagnóstico clínico de HFpEF siendo manejado activamente durante la hospitalización
- vive dentro de las 30 millas del centro médico
- capaz de realizar el consentimiento informado
Criterio de exclusión:
- artritis reumatoide u otra enfermedad inflamatoria/autoinmune
- cáncer, excluyendo el cáncer de piel no melanoma o el cáncer de próstata de bajo grado
- demencia severa/enfermedad de alzheimer
- enfermedad vascular periférica limitante del ejercicio
- enfermedad neuromuscular o disfunción neuromuscular asociada con evento cerebrovascular
- índice de masa corporal ≥40 kg/m2
- coágulo de sangre en las extremidades inferiores o desfibrilador automático implantable o marcapasos
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Estimulación eléctrica neuromuscular
Estimulación eléctrica neuromuscular del cuádriceps.
45 minutos, 5 días a la semana
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Estimulación muscular cuádriceps bilateral
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Sin intervención: Control
Sin control de tratamiento
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Distancia a pie de 6 minutos (6MW)
Periodo de tiempo: Cambio del alta hospitalaria (dentro de 1 día) a 4 semanas después del alta
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6 MW se desarrolló para evaluar la aptitud cardiopulmonar en pacientes con enfermedades pulmonares y cardíacas y se ha validado en pacientes con insuficiencia cardíaca.
Evalúa la distancia que un paciente puede caminar en 6 minutos alrededor de un recorrido estándar.
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Cambio del alta hospitalaria (dentro de 1 día) a 4 semanas después del alta
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Batería de rendimiento físico corto
Periodo de tiempo: Cambio del alta hospitalaria (dentro de 1 día) a 4 semanas después del alta
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La batería de rendimiento físico breve se compone de tres tareas que evalúan el equilibrio, la velocidad de la marcha y la capacidad para levantarse de una silla.
Las unidades en una escala para cada dominio varían de 0 a 4 para una puntuación total de 0 a 12, donde una puntuación más alta indica una mejor función física.
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Cambio del alta hospitalaria (dentro de 1 día) a 4 semanas después del alta
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Resultados Médicos Formulario Corto 36
Periodo de tiempo: Alta hospitalaria (dentro de 1 día) y 4 semanas posteriores al alta
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El Medical Outcomes Short Form 36 es un cuestionario que evalúa la salud autoinformada y el estado funcional físico.
Hay 36 preguntas que reflejan ocho subdominios de salud incluidos en este cuestionario.
Las puntuaciones de cada dominio representan sumas ponderadas de las preguntas en cada subdominio.
Cada escala se transforma directamente en una escala de 0 a 100 en el supuesto de que cada pregunta tiene el mismo peso.
Esta medida representa la puntuación total calculada en todos los subdominios.
Las puntuaciones más bajas representan una peor salud general, mientras que las puntuaciones más altas representan una mejor salud.
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Alta hospitalaria (dentro de 1 día) y 4 semanas posteriores al alta
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Índice de Katz de Independencia en las Actividades de la Vida Diaria
Periodo de tiempo: Alta hospitalaria (dentro de 1 día) y 4 semanas posteriores al alta
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El Índice de Independencia de Katz en las Actividades de la Vida Diaria, comúnmente conocido como ADL de Katz, es el instrumento más apropiado para evaluar el estado funcional como una medida de la capacidad del cliente para realizar actividades de la vida diaria de forma independiente.
Los médicos suelen utilizar la herramienta para detectar problemas en la realización de actividades de la vida diaria y para planificar la atención en consecuencia.
El Índice clasifica la adecuación del desempeño en las seis funciones de bañarse, vestirse, ir al baño, trasladarse, continencia y alimentación.
Los clientes reciben un puntaje de sí/no por su independencia en cada una de las seis funciones.
Una puntuación de 6 indica una función completa, 4 indica un deterioro moderado y 2 o menos indica un deterioro funcional grave.
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Alta hospitalaria (dentro de 1 día) y 4 semanas posteriores al alta
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Lawton Instrumental Activities of Daily Living (IADL) Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de febrero de 2022
Finalización primaria (Actual)
30 de septiembre de 2023
Finalización del estudio (Actual)
30 de septiembre de 2023
Fechas de registro del estudio
Enviado por primera vez
21 de marzo de 2022
Primero enviado que cumplió con los criterios de control de calidad
13 de abril de 2022
Publicado por primera vez (Actual)
21 de abril de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2026
Última verificación
1 de abril de 2025
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00001757
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .