CST+MST Intervention on People Living With Mild-to-moderate Dementia (CST+MST)
Outcome Research Study on the Evaluation of a Combined Treatment of Cognitive Stimulation Therapy and Group Motor Stimulation in People With Mild-to-Moderate Dementia
Non-pharmacological interventions such as Cognitive Stimulation Therapy (CST) and physical activity are recommended for people living with mild-to-moderate dementia. Emerging evidence suggests that combining cognitive and motor interventions may provide synergistic benefits on cognition, mobility, and functional abilities. This study aims to evaluate the effectiveness of a combined CST and Motor Stimulation Treatment (MST) programme.
This multicenter quasi-experimental study will involve 30 clinical centers across five Italian regions. Participants aged ≥65 years with mild-to-moderate dementia will receive 14 combined CST+MST sessions delivered twice weekly over 7 weeks. Assessments will be conducted at baseline, post-intervention, and after 14 weeks by the end of the interventions. Primary outcomes include proportion of responders on the Mini-Mental State Examination (≥2.32 points) and Timed Up and Go test (≥1 point). Secondary outcomes include cognitive, motor, functional, psychological, and caregiver-related measures.
Ethical approval was obtained from the Italian National Ethics Committee in July 2025 (reference number: 2025_0032251). Written informed consent will be obtained from participants and/or their legal representatives, as well as from caregivers involved in the study. All procedures will comply with the Declaration of Helsinki and national data protection regulations. Study findings will be disseminated through peer-reviewed scientific publications and presentations at national and international conferences.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ernesto Palummeri
- Número de teléfono: +39 3312627145
- Correo electrónico: ernesto.palummeri@alisa.liguria.it
Ubicaciones de estudio
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Genova
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Genova, Genova, Italia, 16132
- Reclutamiento
- Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE"
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Contacto:
- Claudio Ivaldi
- Número de teléfono: +39 3477569654
- Correo electrónico: Claudio.Ivaldi@asl3.liguria.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- age ≥ 65 years;
- having been assessed by a Center for Dementia and Cognitive Disorders (CCDD) who diagnosed dementia with any etiology of mild to moderate severity;
- being able to perform a Timed Up and Go test (TUG) regardless of the time taken, i.e. being able to walk independently or with assistance, but without the need for human help during the test;
- having no hearing or visual impairments of a degree that would preclude participation in the interventions.
Exclusion Criteria:
- presence of specific behavioural disorders (delusions, hallucinations, agitation, anxiety, euphoria, disinhibition, irritability, wandering) of a degree that prevents participation in the interventions;
- diseases that contraindicate physical activity (e.g. severe heart failure).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: People living with mild-to-moderate dementia
People living with mild-to-moderate dementia being able to perform a Timed Up and Go test (TUG) regardless of the time taken, i.e. being able to walk independently or with assistance, but without the need for human help during the test, and having no hearing or visual impairments of a degree that would preclude participation in the interventions.
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The intervention will consist of a total of 14 sessions lasting 2 hours each over 7 weeks (twice a week).
The intervention will be delivered in groups of 6-8 patients with similar cognitive abilities and will always be carried out by two operators, a psychologist and a physiotherapist.
The space will be large enough to allow patients to walk easily in a circle; however, adjustments may be made (e.g.
walking on the spot).
Each session will consist of an initial 45-minute CST session followed by an MST session.
The short break scheduled in the CST protocol will be postponed until the end of this intervention and before the MST session.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mini Mental State Examination (MMSE)
Periodo de tiempo: The test will be administered at baseline, at week 7 and at week 14
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A screening neuropsychological test assessing cognitive global function.
The total score is 30.
Higher scores indicate better cognitive performance.
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The test will be administered at baseline, at week 7 and at week 14
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Timed and Up Go Test (TUG)
Periodo de tiempo: Baseline, week 7, and week 14
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TUG test is a simple clinical measure of functional mobility and fall risk.
It records the time (in seconds) needed to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
Scores are interpreted as follows: lower times indicate better mobility, with <10 seconds generally considered normal, 10-20 seconds indicating mild mobility impairment, and >20-30 seconds suggesting increased fall risk and functional limitation, depending on clinical context.
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Baseline, week 7, and week 14
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Colaboradores e Investigadores
Patrocinador
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
- 2025_0032251
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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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