Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study presents the protocol of a prospective, single-center, single-blinded, two-armed randomized controlled trial.
The investigators plan to recruit patients over 65 years of age with degenerative knee arthritis or chronic low back pain. Patients will be randomly divided into two groups with 1:1 allocation.
The intervention group will receive 6 weeks of the IoT-based home exercise program. The IoMT-based home exercise program is implemented to the patients via a smartphone application. The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise (Figure 1). The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
The activity detector records the amount of activity and the speed of movement within the home. The door sensor detects the enter and exit and records the number of outings. The pillbox notifies subjects to take the medication time. The smart-care phone provides emergency call and guardian connection services. The body composition analyzer measures body mass index, fat, and muscle mass.
The primary outcome in patients with degenerative knee arthritis is Western Ontario and McMaster Universities Osteoarthritis. And the primary outcome in patients with chronic low back pain is Oswestry Disability Index. The secondary outcomes are numeric rating scale for pain, 36-Item Short-Form Health Survey, Geriatric Depression Scale, Timed-Up and Go test, and 30s chair sit and stand.
The investigators evaluate primary and secondary outcomes before and after the home exercise programs.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jeongyi Kwon, M.D,PhD
- Número de teléfono: +82-2-3410-2818
- Correo electrónico: jeongyi.kwon@samsung.com
Ubicaciones de estudio
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Seoul, Corea, república de, 06351
- Reclutamiento
- Samsung Medical Center
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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:
- Knee pain for more than 3months, Kellgren-Lawrence grade 2 or higher
- Low back pain for more than 3months
- A person who underdtands the exercise program
- Numeric rating scale of 4 or higher
Exclusion Criteria:
- History of knee surgery
- Systemic inflammatary disease
- History of polyneuropathy
- History of stroke
- Severe heart failure
- Chronic obstructive pulmonary disease
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 |
|---|---|
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Experimental: Home-based exercise program
The subjects will receive 6 weeks of the home exercise program via a smartphone application.
The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise.
The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
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Daily home based exercise program (30min/day, 7days/week for 6 weeks).
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Sin intervención: Exercise brochure
This group will be offered a brochure including number of exercises for back or knee.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis
Periodo de tiempo: baseline
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Knee osteoarthritis functional index (Range: 0-96)
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baseline
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Western Ontario and McMaster Universities Osteoarthritis
Periodo de tiempo: after 6weeks
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Knee osteoarthritis functional index (Range: 0-96)
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after 6weeks
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Oswestry Disability Index
Periodo de tiempo: baseline
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Low back pain functional index (Range: 0-100)
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baseline
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Oswestry Disability Index
Periodo de tiempo: after 6weeks
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Low back pain functional index (Range: 0-100)
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after 6weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Numeric rating scale
Periodo de tiempo: baseline
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Pain score, The higher score means the worse pain (Range: 0-10)
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baseline
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Numeric rating scale
Periodo de tiempo: after 6weeks
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Pain score, The higher score means the worse pain (Range: 0-10)
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after 6weeks
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36-Item Short-Form Health Survey
Periodo de tiempo: baseline
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Qualify of life, The higher score means the better condition (Range: 0-100)
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baseline
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36-Item Short-Form Health Survey
Periodo de tiempo: after 6weeks
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Qualify of life, The higher score means the better condition (Range: 0-100)
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after 6weeks
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Geriatric Depression Scale
Periodo de tiempo: baseline
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Depression score, The higher score means the worse condition (Range: 0-15)
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baseline
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Geriatric Depression Scale
Periodo de tiempo: after 6weeks
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Depression score, The higher score means the worse condition (Range: 0-10)
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after 6weeks
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Timed-Up and Go test
Periodo de tiempo: baseline
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Dynamic balance, The higher score means the worse balance.
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baseline
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Timed-Up and Go test
Periodo de tiempo: after 6weeks
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Dynamic balance, The higher score means the worse balance.
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after 6weeks
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30s chair sit and stand
Periodo de tiempo: baseline
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Balance, The higher score means the better condition.
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baseline
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30s chair sit and stand
Periodo de tiempo: after 6weeks
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Balance, The higher score means the better condition.
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after 6weeks
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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
- 2021-04-004
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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