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CST+MST Intervention on People Living With Mild-to-moderate Dementia (CST+MST)

28. maj 2026 opdateret af: Istituto Superiore di Sanità

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

421

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
    • Genova
      • Genova, Genova, Italien, 16132
        • Rekruttering
        • Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE"
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Cognitive Stimulation Therapy and Motor Stimulation Treatment
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.
Andre navne:
  • CST
  • MST

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mini Mental State Examination (MMSE)
Tidsramme: The test will be administered at baseline, at week 7 and at week 14
A screening neuropsychological test assessing cognitive global function. The total score is 30. Higher scores indicate better cognitive performance.
The test will be administered at baseline, at week 7 and at week 14
Timed and Up Go Test (TUG)
Tidsramme: Baseline, week 7, and week 14
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.
Baseline, week 7, and week 14

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istituto Superiore di Sanità

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. juli 2025

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025_0032251

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

We will share individual participant data (IPD) including baseline demographic and clinical characteristics, outcome measures collected during and after the intervention (e.g., cognitive, functional, and motor assessments), and relevant safety/adverse event data. All shared IPD will be de-identified to ensure participant confidentiality.

IPD-delingstidsramme

At the end of the study

IPD-delingsadgangskriterier

Immediately after the first publication of the results. IPD wil be shared through scientific publications.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Demens

Kliniske forsøg med Cognitive Stimulation Therapy and Motor Stimulation Treatment

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