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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Mini Mental State Examination (MMSE) — 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.
• Timed and Up Go Test (TUG) — 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.

Trial sites (1)

More Istituto Superiore di Sanità trials in Italy

Other trials for the same condition