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- Ensayo clínico NCT07772726
The Effect of IoT-based Smart Exercises System in the Senior Adults: Coordination
Smart Health Care and Innovative Technology Service Model Plan: Development of Innovative Health Promotion System for Senior Adults
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants are divided into two groups: (1) the Control (Ctrl) group and (2) the Smart Exercise (SE) group. Participants in both groups are instructed to perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes.
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system. The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE). Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.
Physical fitness tests, coordination tests, and questionnaires are administered to participants in both groups before and after the 12-week exercise program. Changes in physical fitness, coordination, and questionnaire outcomes are compared between the two groups.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Li-Chieh Kuo, Ph. D.
- Número de teléfono: 886-62353535 Ext. 5908
- Correo electrónico: jkkuo@mail.ncku.edu.tw
Copia de seguridad de contactos de estudio
- Nombre: Chih-Chun Lin, Ph. D.
- Número de teléfono: 886-62757575 Ext. 58420
- Correo electrónico: z9902026@email.ncku.edu.tw
Ubicaciones de estudio
-
-
Taiwan
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Tainan, Taiwan, Taiwán, 701
- Reclutamiento
- National Cheng-Kung University
-
Contacto:
- Li-Chieh Kuo, Ph. D.
- Número de teléfono: 886-62353535 Ext. 5908
- Correo electrónico: jkkuo@mail.ncku.edu.tw
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult over 50 years old
- No significant limb disability or joint deformation
- No history of cardiovascular disease
- Never lost balance due to dizziness in the past 12 months
Exclusion Criteria:
- limb disability or joint deformation
- history of cardiovascular disease
- lost balance due to dizziness in the past 12 months
- cognitive deficits
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Control group
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
|
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
|
|
Experimental: Smart Exercise group
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system.
The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE).
Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.
|
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system.
The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE).
Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
TUG Manual
Periodo de tiempo: baseline
|
The TUG Manual Test evaluates a senior's attentional control and dynamic balance under a motor dual-task condition.
Participants perform the standard Timed Up and Go task-standing, walking three meters, turning, and sitting-while carrying a full glass of water in one hand.
Instructors record the time, with scores over 14.5 seconds indicating a high risk of falling.
|
baseline
|
|
TUG Manual
Periodo de tiempo: after 12-week intervation
|
The TUG Manual Test evaluates a senior's attentional control and dynamic balance under a motor dual-task condition.
Participants perform the standard Timed Up and Go task-standing, walking three meters, turning, and sitting-while carrying a full glass of water in one hand.
Instructors record the time, with scores over 14.5 seconds indicating a high risk of falling.
|
after 12-week intervation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Prueba de caminata de seis minutos
Periodo de tiempo: base
|
Caminar lo más posible en seis minutos y medir la distancia total recorrida.
|
base
|
|
Prueba de caminata de seis minutos
Periodo de tiempo: después de 12 semanas de intervención
|
Caminar lo más posible en seis minutos y medir la distancia total recorrida.
|
después de 12 semanas de intervención
|
|
Prueba de paso de 2 minutos
Periodo de tiempo: base
|
La prueba de paso de 2 minutos es para completar los pasos en 2 minutos.
Se registra el número de pasos completos completados en 2 minutos.
|
base
|
|
Prueba de paso de 2 minutos
Periodo de tiempo: después de 12 semanas de intervención
|
La prueba de paso de 2 minutos es para completar los pasos en 2 minutos.
Se registra el número de pasos completos completados en 2 minutos.
|
después de 12 semanas de intervención
|
|
Prueba de equilibrio de una sola pierna con los ojos abiertos
Periodo de tiempo: base
|
Se le indica al participante que se pare sobre una pierna con el ojo abierto, se registra el número de segundos.
|
base
|
|
Prueba de equilibrio de una sola pierna con los ojos abiertos
Periodo de tiempo: después de 12 semanas de intervención
|
Se le indica al participante que se pare sobre una pierna con el ojo abierto, se registra el número de segundos.
|
después de 12 semanas de intervención
|
|
Índice de fragilidad SOF (Estudio de Fracturas Osteoporóticas) (Cuestionario de función física y estado de salud)
Periodo de tiempo: base
|
Factores de riesgo de fracturas y caídas y ha crecido para analizar varios determinantes del envejecimiento exitoso.
Tres preguntas sobre fragilidad y dos preguntas sobre depresión.
|
base
|
|
Índice de fragilidad SOF (Estudio de Fracturas Osteoporóticas) (Cuestionario de función física y estado de salud)
Periodo de tiempo: después de 12 semanas de intervención
|
Factores de riesgo de fracturas y caídas y ha crecido para analizar varios determinantes del envejecimiento exitoso.
Tres preguntas sobre fragilidad y dos preguntas sobre depresión.
|
después de 12 semanas de intervención
|
|
SARC-F
Periodo de tiempo: base
|
El cuestionario SARC-F es una prueba de diagnóstico rápido para SARCopenia.
El cuestionario contiene cinco ítems, que son Fuerza, Ayuda para caminar, Levantarse de una silla, Subir escaleras y Caídas.
Las puntuaciones van de 0 a 10, con 0 a 2 puntos para cada componente.
Una puntuación igual o superior a 4 es predictiva de sarcopenia y malos resultados.
|
base
|
|
SARC-F
Periodo de tiempo: después de 12 semanas de intervención
|
El cuestionario SARC-F es una prueba de diagnóstico rápido para SARCopenia.
El cuestionario contiene cinco ítems, que son Fuerza, Ayuda para caminar, Levantarse de una silla, Subir escaleras y Caídas.
Las puntuaciones van de 0 a 10, con 0 a 2 puntos para cada componente.
Una puntuación igual o superior a 4 es predictiva de sarcopenia y malos resultados.
|
después de 12 semanas de intervención
|
|
EQ-5D (EuroQol- 5 Dimensions)
Periodo de tiempo: baseline
|
EQ-5D is a standardized instrument with 5-item questionnaire for measuring generic health status.
EQ-5D was first introduced in 1990 by the EuroQol Group.
In which health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333(having extreme problems in all dimensions).
|
baseline
|
|
BMI
Periodo de tiempo: basline
|
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
|
basline
|
|
BMI
Periodo de tiempo: after 12-week intervention
|
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
|
after 12-week intervention
|
|
Up and Go test
Periodo de tiempo: baseline
|
Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
|
baseline
|
|
Up and Go test
Periodo de tiempo: after 12-week intervention
|
Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
|
after 12-week intervention
|
|
30 second chair stand test
Periodo de tiempo: baseline
|
Number of full stands that can completed in 30 seconds with arms folded across chest.
|
baseline
|
|
30 second chair stand test
Periodo de tiempo: after 12-week intervention
|
Number of full stands that can be completed 30 seconds with arms folded across chest.
|
after 12-week intervention
|
|
SMI
Periodo de tiempo: baseline
|
Skeletal muscle mass index (SMI), which is the sum of the muscle masses of the four limbs as appendicular skeletal mass (ASM) in kilograms divided by the square of height in meters, is detected by TANITA MC-780MA body composition analyzer.
|
baseline
|
|
SMI
Periodo de tiempo: after 12-week intervention
|
Skeletal muscle mass index (SMI), which is the sum of the muscle masses of the four limbs as appendicular skeletal mass (ASM) in kilograms divided by the square of height in meters, is detected by TANITA MC-780MA body composition analyzer.
|
after 12-week intervention
|
|
Back scratch
Periodo de tiempo: baseline
|
Back scratch with one hand reaching over shoulder and one up the middle of the back, the distance (cm) between extended middle fingers is recorded.
|
baseline
|
|
Back scratch
Periodo de tiempo: after 12-week intervention
|
Back scratch with one hand reaching over shoulder and one up the middle of the back, the distance (cm) between extended middle fingers is recorded.
|
after 12-week intervention
|
|
Chair sit-&-reach test
Periodo de tiempo: baseline
|
From a sitting position at front of chair, with leg extended and hands reaching toward toes, the distance (cm) between extended fingers and tip of toe is recorded.
|
baseline
|
|
Chair sit-&-reach test
Periodo de tiempo: after 12-week intervention
|
From a sitting position at front of chair, with leg extended and hands reaching toward toes, the distance (cm) between extended fingers and tip of toe is recorded.
|
after 12-week intervention
|
|
Hand grip strength test
Periodo de tiempo: baseline
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
baseline
|
|
Hand grip strength test
Periodo de tiempo: after 12-week intervention
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
after 12-week intervention
|
|
Extremity strength
Periodo de tiempo: baseline
|
Extremity strength test is performed by handheld dynamometer
|
baseline
|
|
Extremity strength
Periodo de tiempo: after 12-week intervention
|
Extremity strength test is performed by handheld dynamometer
|
after 12-week intervention
|
|
Soda pop coordination
Periodo de tiempo: baseline
|
The Soda Pop Coordination Test assesses manual dexterity and hand-eye coordination.
Participants use their dominant hand to flip and reposition three soda cans across six marked points as quickly as possible.
Completion time is recorded.
|
baseline
|
|
Soda pop coordination
Periodo de tiempo: after 12-week intervention
|
The Soda Pop Coordination Test assesses manual dexterity and hand-eye coordination.
Participants use their dominant hand to flip and reposition three soda cans across six marked points as quickly as possible.
Completion time is recorded.
|
after 12-week intervention
|
|
Ruler drop test
Periodo de tiempo: baseline
|
The Ruler Drop Test assesses visual reaction time and hand-eye coordination.
Participants catch a ruler dropped without warning using their dominant hand.
The falling distance is recorded to calculate reaction time in milliseconds.
|
baseline
|
|
Ruler drop test
Periodo de tiempo: after 12-week intervation
|
The Ruler Drop Test assesses visual reaction time and hand-eye coordination.
Participants catch a ruler dropped without warning using their dominant hand.
The falling distance is recorded to calculate reaction time in milliseconds.
|
after 12-week intervation
|
|
Box and blocks test
Periodo de tiempo: baseline
|
The Box and Block Test assesses gross manual dexterity and upper-extremity function.
Participants transfer blocks across a partition using one hand at a time.
The number of blocks transferred within one minute is recorded.
|
baseline
|
|
Box and blocks test
Periodo de tiempo: after 12-week intervation
|
The Box and Block Test assesses gross manual dexterity and upper-extremity function.
Participants transfer blocks across a partition using one hand at a time.
The number of blocks transferred within one minute is recorded.
|
after 12-week intervation
|
|
EQ-5D (EuroQol- 5 Dimensions)
Periodo de tiempo: after 12-week intervention
|
EQ-5D is a standardized instrument with 5-item questionnaire for measuring generic health status.
EQ-5D was first introduced in 1990 by the EuroQol Group.
In which health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333(having extreme problems in all dimensions).
|
after 12-week intervention
|
|
QUEST (Questionnaire for satisfaction)
Periodo de tiempo: after 12-week intervention
|
The 8 items of the questionnaire included Dimensions, Weight, Ease in Adjusting, Safety and Security, Durability, Ease of Use, Comfortable, and Effectiveness.
Each item employed a 5-point scale, with 1-point representing not satisfied at all, and 5-point representing very satisfied.
Evaluation of Satisfaction with Assistive Technology.
|
after 12-week intervention
|
|
System Usability Scale (SUS)
Periodo de tiempo: after 12-week intervention
|
The System Usability Scale (SUS) is a reliable, 10-item Likert-scale questionnaire utilized to provide a global evaluation of a system's usability and user-friendliness.
Each item is scored from 1 (strongly disagree) to 5 (strongly agree).
Higher scores indicate better system usability.
|
after 12-week intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
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
- B-BR-106-072B
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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