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

Official title

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

Overview

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.

Interventions

• Behavioral 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 a

Primary outcome measures

• Mini Mental State Examination (MMSE) [Time frame: The test will be administered at baseline, at week 7 and at week 14]
• Timed and Up Go Test (TUG) [Time frame: Baseline, week 7, and week 14]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE" — Genova

Identifiers

NCT: NCT07625241 · 2025_0032251

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗