- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02470143
a Bike Application to Support Cardiac Patient (BackonBike)
Pilot Study, How a Bike Application Can Support Cardiac Patients in Their Rehabilitation Program?
The pilot study will investigate the usability of a mobile cycling application in a cardiac patient population during a one month study period.
The application's effectiveness regarding ability to reduce fear and increase motivation to exercise will be assessed.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This pilot study investigates the use of a mobile cycling application for patients with a cardiac disease that was developed by the Expertise Centre for Digital Media of Hasselt University in collaboration with the Faculty of Medicine & Life Sciences of Hasselt University. During the pilot study, the use of the cycling application and its impact on fear and motivation of patients with a cardiac disease during the rehabilitation is studied. The cycling application will be used on a smartphone, in combination with a wrist-worn heart rate monitor.
During the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment. Through questionnaires and interviews, the patients' experiences with respect to fear and motivation will be collected. Furthermore, the usability of the cycling application is evaluated through these questionnaires and interviews.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Hasselt, Bélgica
- Jessa Ziekenhuis
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only.
- Patients that have completed the standard cardiac rehabilitation program
- Patients who have access to a computer and a WiFi internet connection
- Patients that are able to go to the rehabilitation centre ReGo of Jessa Hospital
- Patients who signed the informed consent document
Exclusion Criteria:
- Patients with a history of VF, sustained VT and/or supraventricular tachycardia during the last 6 months before enrollment.
- Patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle.
- Patients with a pacemaker.
- Non-Dutch speaking patients
- Patients who simultaneously participate in another study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Bike application arm
The bike application arm contains cardiac patients that will be instructed to use the cycling application during a one month period.
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The intervention patients will use the cycling application on a smartphone, in combination with a wrist-worn heart rate monitor.
During the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Impact on motivation
Periodo de tiempo: up to week 4
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up to week 4
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Usability of the cycling application
Periodo de tiempo: Up to week 4
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By means of a questionnaire and an interview, the participants are asked about the usability of the application.
This information will give insights in parts of the application that could be improved considering the usability.
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Up to week 4
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Impact on fear
Periodo de tiempo: up to week 4
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By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour
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up to week 4
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Ines Frederix, drs., Universiteit Hasselt/ Jessa ziekenhuis
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (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
- PDEN-IFRE 02
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