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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 421
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).