Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Evaluations of Behavioral Disorders
研究概览
简要总结
Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of disability with elevated social costs. Alternative solutions to the standard pharmacological therapies have been studied in order to reduce the use of medications that frequently generates side effects and worsen patients' quality of life. A recent alternative treatment for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this approach is still mater of debate. Therefore, the aim of this trial will be to analyze the effects of EET, in people with severe AD.
详细描述
Since Homo sapiens evolved in a natural environment, an intrinsic physiologic and psychological positive reaction to nature has been developed. Accordingly, emerging literature highlights the positive effect of therapeutic gardens, as environmental ecological therapy (EET) on the reduction of behavioral disorders (BD) and the preservation of cognitive functions in patients with Alzheimer's disease (AD).
Despite these promising preliminary studies, limited data are available on the effectiveness of EET in individuals with advanced AD. Therefore, the aim of the current trial will be to evaluate the effectiveness of EET on AD symptoms in patients with advanced AD.
Participants with advanced AD will be selected from among residents of the Alzheimer's care units of the Mons. Mazzali Foundation (Mantua, Italy). Selected participants will be randomly assigned to a treatment group (TR), or to a control group (CTRL).
Participants assigned to TR group will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months. Individuals assigned to the CTRL group will be treated with a standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, 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
- •Person with Alzheimer's disease.
排除标准
- •Bedridden patients.
结局指标
主要结局
Evaluations of Behavioral Disorders
时间窗: PRE and POST 6 months of treatment
Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome.
Evaluation of Cognitive Status (Score 0-30)
时间窗: PRE and POST 6 months of treatment
Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome.
次要结局
- Number of Medications(PRE and POST 6 months of treatment)
- Body Composition (Kilograms of Fat Free Mass)(PRE and POST 6 months of treatment)
- Number of Patients Treated With Quetiapine(PRE and POST 6 months of treatment)
- Systolic Blood Pressure (mmHg)(PRE and POST 6 months of treatment)
- Diastolic Blood Pressure (mmHg)(PRE and POST 6 months of treatment)
- Blood Glucose (mg/dl)(PRE and POST 6 months of treatment)
- Blood Cholesterol HDL (mg/dl)(PRE and POST 6 months of treatment)
- Blood Cholesterol LDL (mg/dl)(PRE and POST 6 months of treatment)
- Daily Energy Expenditure (Kcal/Day)(PRE and POST 6 months of treatment)
- Salivary Cortisol (Nmol/l)(PRE and POST 6 months of treatment)
- Number of Patients Treated With Ticlopidin(PRE and POST 6 months of treatment)
- Evaluation of Activity of Daily Life(PRE and POST 6 months of treatment)
- Number of Patients Treated With Memantine(PRE and POST 6 months of treatment)
- Number of Patients Treated With Citalopram(PRE and POST 6 months of treatment)
- Number of Patients Treated With Donepezil(PRE and POST 6 months of treatment)
研究者
Massimo Venturelli, PhD
Research Fellow
Universita di Verona