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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ernesto Palummeri
- Telefoonnummer: +39 3312627145
- E-mail: ernesto.palummeri@alisa.liguria.it
Studie Locaties
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Genova
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Genova, Genova, Italië, 16132
- Werving
- Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE"
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Contact:
- Claudio Ivaldi
- Telefoonnummer: +39 3477569654
- E-mail: Claudio.Ivaldi@asl3.liguria.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Mini Mental State Examination (MMSE)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025_0032251
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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