Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Effects and Mechanisms of a Virtual Reality-Based Multidomain Intervention in Older Adults With Cognitive Frailty: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effects of a virtual reality (VR) multidomain intervention on cognitive function in older adults with cognitive frailty and explore its underlying mechanisms.
Participants will receive either supervised VR training twice weekly for 8 weeks or multidomain health education. The VR program combines cognitive training, physical exercise, nutrition education, and emotional support.
Cognitive function, physical function, emotional symptoms, and nutritional status will be assessed at baseline and Week 8. Functional near-infrared spectroscopy will assess brain activity to explore potential mechanisms. Intervention feasibility, acceptability, and safety will also be evaluated.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Qian Liu
- Número de teléfono: Master's degre +86 13175250076
- Correo electrónico: shiliuqiana@163.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age >60 years.
- FFP score ≥1.
- MMSE ≥24 and either SCD-Q9 ≥5 or MoCA <26.
- ADL score ≤26.
- Ability to follow instructions, communicate discomfort, and safely participate in VR training.
- Written informed consent.
Exclusion Criteria:
- Dementia, stroke, Parkinson's disease, spinal cord injury, or epilepsy.
- Medical, psychiatric, or neurological conditions that prevent safe participation.
- Severe or recurrent vertigo, motion sickness, or intolerance to VR.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Virtual Reality Multidomain Intervention
Participants will receive supervised virtual reality multidomain training twice weekly for 8 weeks, for a total of 16 sessions. Each session is planned to last approximately 45 minutes, including instruction, warm-up, intermittent VR training, breaks, and task transitions. The program combines cognitive training, physical exercise, nutrition education, and emotional support. Task difficulty and training duration will be adjusted according to individual abilities and tolerance. |
A supervised VR program combining cognitive training, physical exercise, nutrition education, and emotional support. Participants attend two sessions weekly for 8 weeks, totaling 16 sessions. Each 45-minute session includes instruction, warm-up, approximately 25 minutes of intermittent VR training, and breaks. VR training includes approximately 10 minutes of cognitive training, 10 minutes of physical exercise, and 5 minutes of nutrition education or emotional support. Nutrition and emotional support activities alternate between the two weekly sessions. VR familiarization is provided before formal training. Task difficulty and training duration are adjusted to individual abilities and tolerance. |
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Comparador activo: Multidomain Health Education
Participants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. |
Participants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. The educational content addresses the same health domains as the VR intervention. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline and Week 8 (end of intervention)
|
The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. |
Baseline and Week 8 (end of intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Short Physical Performance Battery
Periodo de tiempo: Baseline and Week 8 (end of intervention)
|
The Short Physical Performance Battery (SPPB) will be used to assess lower-extremity physical function through standing balance, walking speed, and repeated chair stands. Total scores range from 0 to 12, with higher scores indicating better physical performance. |
Baseline and Week 8 (end of intervention)
|
|
Fried Frailty Phenotype
Periodo de tiempo: Baseline and Week 8 (end of intervention)
|
The Fried Frailty Phenotype (FFP) will be used to assess physical frailty based on five criteria: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Total scores range from 0 to 5, with higher scores indicating greater frailty. |
Baseline and Week 8 (end of intervention)
|
|
Timed Up and Go Test (TUG)
Periodo de tiempo: Baseline and Week 8 (end of intervention)
|
The Timed Up and Go (TUG) test will be used to assess functional mobility. Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. Completion time is recorded in seconds, with shorter times indicating better functional mobility. |
Baseline and Week 8 (end of intervention)
|
|
Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline and Week 8 (end of intervention)
|
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms over the preceding two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. |
Baseline and Week 8 (end of intervention)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- PUMCSON-2025-21
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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