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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ernesto Palummeri
- Numéro de téléphone: +39 3312627145
- E-mail: ernesto.palummeri@alisa.liguria.it
Lieux d'étude
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Genova
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Genova, Genova, Italie, 16132
- Recrutement
- Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE"
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Contact:
- Claudio Ivaldi
- Numéro de téléphone: +39 3477569654
- E-mail: Claudio.Ivaldi@asl3.liguria.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mini Mental State Examination (MMSE)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025_0032251
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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