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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04949334
Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ruey Chen, PhD
- Número de teléfono: 8620 886-2-2249088
- Correo electrónico: 18622@s.tmu.edu.tw
Copia de seguridad de contactos de estudio
- Nombre: Tzu-Ang Chen, MD
- Número de teléfono: 886-915855505
- Correo electrónico: b101103035@tmu.edu.tw
Ubicaciones de estudio
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New Taipei City, Taiwán, 235
- Reclutamiento
- Shuang Ho Hospital, Taipei Medical University
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Contacto:
- Ruey Chen, PhD
- Número de teléfono: 8620 886-2-2249088
- Correo electrónico: 18622@s.tmu.edu.tw
-
Contacto:
- Tzu-Ang Chen, MD
- Número de teléfono: 886-915855505
- Correo electrónico: b101103035@tmu.edu.tw
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ischemic stroke diagnosed by MRI
- Age over 20 years old
- No worsening of stroke or second stroke this time
Exclusion Criteria:
- Unable to understand instructions normally, or communication difficulties
- Patients with endotracheal tube or tracheostomy
- Angina in recent 3 months, myocardial infarction, heart failure
- Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia
- Patients with untreated hernias
- Pregnant
- Ongoing fever (body temperature>38.5°C)
- Poor hypertension control (higher than 170/100 mmHg three days before intervention)
- Patients who have had cerebral hemorrhage or aneurysm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Dofin Breathing Strength Builder
Usual post stroke care and respiratory muscle training
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If the patient's condition is stable, respiratory muscle training will be performed under Dofin Breathing Strength Builder 7 days after stroke. The patient will receive respiratory muscle training by repetition of 30 times, two courses per day, x 7 days, for three weeks. The initial load was set at 30% of the participants' maximal baseline strength and increased weekly at intervals of 2 cmH2O. |
Sin intervención: Usual post stroke care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Respiratory muscle function-1.1
Periodo de tiempo: Baseline
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MEP (maximal expiratory pressure)
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Baseline
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Respiratory muscle function-1.2
Periodo de tiempo: Within one week after training
|
MEP (maximal expiratory pressure)
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Within one week after training
|
Respiratory muscle function-1.3
Periodo de tiempo: Twelve weeks after training
|
MEP (maximal expiratory pressure)
|
Twelve weeks after training
|
Respiratory muscle function-2.1
Periodo de tiempo: Baseline
|
MIP (maximal inspiratory pressure)
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Baseline
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Respiratory muscle function-2.2
Periodo de tiempo: Within one week after training
|
MIP (maximal inspiratory pressure)
|
Within one week after training
|
Respiratory muscle function-2.3
Periodo de tiempo: Twelve weeks after training
|
MIP (maximal inspiratory pressure)
|
Twelve weeks after training
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dyspnea.1
Periodo de tiempo: Baseline
|
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS).
MBS can go from 0-10, 10 is the more severe condition.
|
Baseline
|
Dyspnea.2
Periodo de tiempo: Within one week after training
|
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS).
MBS can go from 0-10, 10 is the more severe condition.
|
Within one week after training
|
Dyspnea.3
Periodo de tiempo: Twelve weeks after training
|
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS).
MBS can go from 0-10, 10 is the more severe condition.
|
Twelve weeks after training
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Exercise tolerance.1
Periodo de tiempo: Baseline
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Exercise tolerance assessed by six-minute walk test (6MWT).
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Baseline
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Exercise tolerance.2
Periodo de tiempo: Within one week after training
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Exercise tolerance assessed by six-minute walk test (6MWT).
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Within one week after training
|
Exercise tolerance.3
Periodo de tiempo: Twelve weeks after training
|
Exercise tolerance assessed by six-minute walk test (6MWT).
|
Twelve weeks after training
|
Body composition.1
Periodo de tiempo: Baseline
|
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
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Baseline
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Body composition.2
Periodo de tiempo: Within one week after training
|
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
|
Within one week after training
|
Body composition.3
Periodo de tiempo: Twelve weeks after training
|
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
|
Twelve weeks after training
|
Life quality.1
Periodo de tiempo: Baseline
|
Quality of life assessed by Short-form 12 (SF-12).
SF-12 can go from 0-100, 100 is the better life quality.
|
Baseline
|
Life quality.2
Periodo de tiempo: Within one week after training
|
Quality of life assessed by Short-form 12 (SF-12).
SF-12 can go from 0-100, 100 is the better life quality.
|
Within one week after training
|
Life quality.3
Periodo de tiempo: Twelve weeks after training
|
Quality of life assessed by Short-form 12 (SF-12).
SF-12 can go from 0-100, 100 is the better life quality.
|
Twelve weeks after training
|
Swallowing.1
Periodo de tiempo: Baseline
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Swallowing function assessed by the Functional Oral Intake Scale (FOIS).
The score can go from 1-7, 7 is the better oral intake condition.
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Baseline
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Swallowing.2
Periodo de tiempo: Within one week after training
|
Swallowing function assessed by the Functional Oral Intake Scale (FOIS).
The score can go from 1-7, 7 is the better oral intake condition.
|
Within one week after training
|
Swallowing.3
Periodo de tiempo: Twelve weeks after training
|
Swallowing function assessed by the Functional Oral Intake Scale (FOIS).
The score can go from 1-7, 7 is the better oral intake condition.
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Twelve weeks after training
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- N202009012
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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