Eficacia y Seguridad del Ejercicio Físico Estructurado en el Hogar en Pacientes con Accidente Cerebrovascular Isquémico Agudo (HOPE-STROKE 2)
Eficacia y Seguridad del Ejercicio Físico Estructurado Domiciliario en Pacientes con Ictus Isquémico Agudo: un Ensayo Controlado Aleatorizado, Abierto, con Evaluador Ciego (HOPE-STROKE 2)
This study is a randomized controlled, open-label, blinded endpoint trial. The investigators aim to assess the efficacy and safety of home-based structured physical exercise in participants with acute ischemic stroke.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study population is participants with acute ischemic stroke within 14 days of onset. All participants are randomly assigned to the exercise intervention group or the control group in a 1:1 ratio. In the exercise intervention group, participants will undergo 90 days of home-based structured physical exercise guidance. The individualized exercise prescription will be determined based on each participant's overall condition. In the control group, participants will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. Both groups of participants will receive standard medical management based on the latest guidelines from the American Heart Association/American Stroke Association.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana
- Xuanwu Hospital, Capital Medical University, 100053
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Anhui
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Fuyang, Anhui, Porcelana
- Taihe Hospital of Traditional Chinese Medicine
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Suzhou, Anhui, Porcelana, 234000
- Suzhou Municipal Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana
- Beijing Pinggu District Hospital
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Henan
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Zhoukou, Henan, Porcelana
- Xihua County People's Hospital
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Xinjiang
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Shihezi, Xinjiang, Porcelana, 836800
- Shihezi People's Hospital
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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:
- Age 18 years or greater, male or female;
- Acute ischemic stroke onset within 14 days;
- modified Rankin scale (mRS) score ≤ 3;
- Signed informed consent from the patients or the legally authorized representatives.
Exclusion Criteria:
- Stroke progression within the past 3 days (defined as an increase in NIHSS score of ≥4 points or an increase in any single item of ≥2 points);
- Concurrent osteoarthritis, fractures, deep vein thrombosis, unstable angina, severe heart diseases, respiratory diseases, or amputation that may theoretically make it difficult for participants to complete the physical exercise or ambulation;
- Concurrent movement disorders such as Parkinson's disease or Parkinsonism;
- Patients who have engaged in regular aerobic physical activity within the past 6 months, defined as more than 150 minutes of moderate-intensity aerobic physical activity; or more than 75 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week;
- Unable to comply with the study procedures or follow-up due to psychiatric, cognitive, or emotional disorders;
- Known pregnancy or lactation, or a positive pregnancy test;
- Currently participating in another drug or device study;
- Life expectancy less than 1 year;
- Unable to communicate using a smartphone;
- Other conditions considered by investigators to be unsuitable for inclusion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise intervention group
Home-based structured physical exercise guidance. |
Subjects will undergo 90 days of home-based structured physical exercise guidance. |
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Sin intervención: Control group
Subjects will not receive structured physical exercise guidance but are encouraged to engage in regular physical exercise. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Cambio en la distancia de la prueba de caminata de 6 minutos
Periodo de tiempo: Entre la línea de base y los 90 días
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Entre la línea de base y los 90 días
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frecuencia cardíaca en reposo
Periodo de tiempo: 90 días
|
90 días
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|
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Presión arterial en reposo
Periodo de tiempo: 90 días
|
90 días
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Mean daily step count
Periodo de tiempo: 90 days and 1year
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90 days and 1year
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|
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Proportion of patients with mRS score 0-1
Periodo de tiempo: 90 days and 1year
|
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
90 days and 1year
|
|
Physical Activity Scale for the Elderly (PASE) score
Periodo de tiempo: 90 days and 1year
|
This test assesses physical activity, including leisure, household, and occupational activity. Score range: minimum 0 to maximum 400 or more. Higher score means a better outcome. |
90 days and 1year
|
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Short Physical Performance Battery (SPPB) score
Periodo de tiempo: 90 days and 1year
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This test measures levels of lower extremity function. The SPPB ranges from 0 to 12, with higher scores indicating better outcomes. |
90 days and 1year
|
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Patient Health Questionnaire-9 (PHQ-9) score
Periodo de tiempo: 90 days and 1year
|
This test screens for depression. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse outcomes. |
90 days and 1year
|
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Mini Montreal Cognitive Assessment score
Periodo de tiempo: 90 days
|
This test measures levels of cognitive function. This test ranges from 0 to 15, with higher scores indicating better outcomes. |
90 days
|
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EQ-5D-5L and EQ-VAS
Periodo de tiempo: 90 days and 1year
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The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicate worse quality of life. |
90 days and 1year
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Rate of Falls
Periodo de tiempo: Within 90 days and 1year after randomization
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Within 90 days and 1year after randomization
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All-cause death
Periodo de tiempo: Within 90 days and 1year after randomization
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Within 90 days and 1year after randomization
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Change in 6-Minute Walk Test Distance
Periodo de tiempo: Between baseline and 1 year
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Between baseline and 1 year
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HOPE-STROKE 2
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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