- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01250600
Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
Application of Intelligent Wireless and Portable Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
Although a lot of evidence and guidelines recommend that patients have cardiac rehabilitation, in reality, the actual rate cardiac patients entering cardiac rehabilitation program is low, usually less than one third. One of the main hindrances of patients participating cardiac rehabilitation program is insufficient number of medical institutions that can provide rehabilitation services. Patients usually cannot perform exercise program under medical professionals monitoring without having to go far. This spatial and temporal difficulty led to the low rate of patients taking cardiac rehabilitation program. The risk of patients to do exercise is higher than healthy adult.
This project will develop the intelligent portable remote care system for cardiopulmonary exercise to provide an instant ECG monitoring service through the integration of front-end wireless ECG measuring devices, expert system, and back-end tele-care platform. Many patients are inconvenient to go to large hospital regularly for cardiac rehabilitation training. This project will help them to exercise at home after once or twice rehabilitation training in clinic for each month and the medical professional will supervise remotely to see how much exercise they did. For that reason the project can help to break through spatial and temporal difficulty of having cardiac rehabilitation, so that cardiac rehabilitation can be help more patients. Patients have this tele-care system while they are doing exercise at home, the built-in heart rate and cardiac rhythm warning function will remind them to take a break, even to take medical treatment. More importantly, the ECG signal can be almost immediately (real time) uploaded by network to the chest pain unit of hospital. The cardiology expert will be aware of the warning at the first moment. This is an important protection to patients' safety of doing rehabilitation sports at home.
This randomized control trial will recruit 80 patients who had myocardial infarction within 6 weeks, and are not able to attend a hospital based cardiac rehabilitation program regularly. All patient will undergo a three-month home exercise program under the instruction provided by the physiatrists and physiotherapists. Forty of them (the remote-care group) will use the intelligent portable remote care system for cardiopulmonary exercise to monitor their exercise intensity and cardiac rhythm during exercise. The other 40 patients (the control group) undertake the exercise program at home without using the remote care system. The efficacy and safety of exercise program will be compared between the two groups.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nai-Hsin Meng, M.D.
- Número de teléfono: 2380 886-4-22052121
- Correo electrónico: nsmeng@ms13.hinet.net
Ubicaciones de estudio
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Taichung, Taiwán, 404
- China Medical University Hospital
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Investigador principal:
- Nai-Hsin Meng, M.D.
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Contacto:
- Nai-Hsin Meng, M.D.
- Número de teléfono: 2380 886-4-22052121
- Correo electrónico: nsmeng@ms13.hinet.net
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Sub-Investigador:
- Pei-Yu Yang, MD, Msc
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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:
- within 6 weeks after an acute myocardial infarction
- not able to attend a hospital based cardiac rehabilitation program regularly
Exclusion Criteria:
- with left ventricular ejection fraction lower than 40%
- history of cardiac arrest
- history of cardiogenic shock, heart failure
- complicated arrhythmia
- abnormal exercise hemodynamics: blood pressure not increased with exercise
- any other physical/psychological condition that hinders the patient's walking ability
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Remote-care
Home exercise monitored by the remote care system
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Daily home exercise for 3 months
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Comparador activo: Control
Home exercise under expert's instruction
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Daily home exercise for 3 months
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in exercise capacity at 3 months
Periodo de tiempo: baseline and after a 3-month exercise program
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6-minute walk test and maximum oxygen uptake obtained by a graded exercise test
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baseline and after a 3-month exercise program
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in quality of life at 3 months.
Periodo de tiempo: baseline and after a 3-month exercise program
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Quality of life questionnaires, including SF-36
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baseline and after a 3-month exercise program
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Change from baseline in physical activities at 3 months.
Periodo de tiempo: baseline and after a 3-month exercise program
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The International Physical Activity Questionnaire
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baseline and after a 3-month exercise program
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nai-Hsin Meng, M.D., China Medical University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- CMU99-NCTU-12
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