Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Compare the effectiveness of adding biweekly dance class for 4 months on behavioral and psychological symptoms of dementia in institutionalized older adults compared to usual care alone.
研究概览
简要总结
It is estimated that the prevalence of dementia in France is 5% for people over 65 years of age and that this increases to 18% for people over 75 years of age. Behavioral disorders are frequent in patients with dementia and are the main cause of institutionalization, representing up to 50% of cases. Dementia syndromes can be translated into behavioral and psychological symptoms of dementia (BPSD), which are defined as perceptual, mood or behavioral disorders. To date, there is no cure for dementia, but certain measures can be taken to reduce symptoms. The HAS suggests that physical exercise would reduce BPSD and could improve the ability to perform activities of daily living or slow down the cognitive decline of this type of patient. Indeed, several articles have highlighted the benefits of physical activity in demented patients. A meta-analysis has shown a significant decrease in BPSD via the Neuropsychiatric Inventory (NPI) score. Nevertheless, it is often observed that there is a difficulty in adhering to the program in very elderly population groups. Dance is a complete physical activity that integrates physical, cognitive and social elements. A meta-analysis has shown that dance has a significant effect on global cognition but also on neuroplasticity and physical functioning in patients with mental disorders. The music component of dance also has an effect on the behavioral problems of demented patients, stimulating language ability and social and emotional function.
However, at present, no study of good methodological quality has been able to demonstrate the effectiveness of dance-based physical activity for the treatment of dementia symptoms. As a result of these findings, the APAISE project was developed and should help slow the onset of BPSD in patients with dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Institutionalized patient (male or female) over 65 years of age ;
- •Patient with behavioral problems, as measured by an NPI-ES ≥ 4 on any item and an NPI-ES impact scale ≥ 3 ;
- •Patient able to mobilize the upper body at a minimum (arms, trunk, head);
- •Medication (antipsychotics, antidepressants, anxiolytics and related hypnotics) without major modification for at least 30 days prior to inclusion after medical advice;
- •Possibility of including patients under guardianship or curatorship;
- •Patient affiliated to a social security plan;
- •Obtaining consent from the patient or legal representative.
排除标准
- •Inability of the patient to follow the sessions (e.g., major visual/auditory disabilities), difficult follow-up, or any other reason at the discretion of the investigator;
- •Inability of the health care team to complete the NPI-ES questionnaire for the patient;
- •Patient has a concurrent psychiatric disorder (e.g., bipolar disorder, schizophrenia, or other).
结局指标
主要结局
Compare the effectiveness of adding biweekly dance class for 4 months on behavioral and psychological symptoms of dementia in institutionalized older adults compared to usual care alone.
时间窗: 4 months
The primary endpoint was the overall score on the validated Neuropsychiatric Inventory questionnaire, completed by the health care teams. This questionnaire will be done at inclusion (day 0) and after 4 months of dance therapy for the experimental group or usual care alone for the control group.This questionnaire allows to highlight behavioral disorders in patients suffering from dementia according to 10 behavioral domains and 2 neurovegetative variables (sleep and appetite).
次要结局
- evolution of behavioral problems(- 8 and 12 months for the experimental group- 12 and 16 months for the control group)
- activity frequency of dementia patients(- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group)
- collection of drugs(- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group)
- program membership(12 months for the experimental group16 months for the control group)
- evaluation of cognitive functions(- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group)
- autonomy or degree of dependence(- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group)
- state of depression(- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group)
- contribution of dance-based physical activity for trained caregivers(8, 12 and 16 months)
- minimal motor and postural possibilities(- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group)