The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study, Biomarker and Health Service Research Analyses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,212
- 试验地点
- 3
- 主要终点
- Global Cognition
研究概览
简要总结
A study in Finland found that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. The SINGER study is a 2-year randomized controlled trial that aims to test the efficacy and safety of these lifestyle changes, including diet and cardiovascular risk factor management, cognitive and physical exercises, in delaying cognitive decline in older adults at risk of dementia.
详细描述
Results from a population-based 2-year clinical trial, the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), demonstrated that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. Currently, no pharmacological treatment options that can rival these effects. Thus, there is an urgent need to test the generalizability, adaptability, and sustainability of these findings in Singaporean populations. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. Hence, the next step was to conduct a larger scale SINGER trial to determine the efficacy of these interventions in Singapore. If the interventions are found to be effective and safe with high applicability and scalability, the study will provide important clinical and public health implications to a rapidly increasing ageing population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60-80 years
- •Able to understand English/Chinese
- •Risk of dementia: Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score ≥6 indicating the presence of modifiable risk factors Modifiable lifestyle factors (fulfilling at least one of the following LIBRA index for diet, cognitive activity, physical activity)
- •Cognitive performance at the mean level or slightly lower than expected for age (MoCA ≥18, ≤27)
- •No plans to travel outside of Singapore for an extended period of time over the course of the study
- •Free of physical disabilities that preclude participation in the study
- •Willing to complete all study-related activities for 24 months
- •Willing to be randomized to either lifestyle intervention group
排除标准
- •malignant diseases
- •major depression
- •symptomatic cardiovascular disease
- •revascularisation within 1 year
- •severe loss of vision, hearing or communicative ability
- •other conditions inhibiting from safe engagement in the prescribed intervention and other conditions preventing cooperation, as judged by the study physician
研究组 & 干预措施
Self-Guided Intervention
General health information provided to participants.
干预措施: Self-Guided Intervention (Behavioral)
Structured Lifestyle Intervention
Structured lifestyle modification program developed for participants targeting diet, physical exercise, cognitive training, and social stimulation.
干预措施: Structured Lifestyle Intervention (Behavioral)
结局指标
主要结局
Global Cognition
时间窗: Up to 2 years
Global cognition measured using the modified Neuropsychological Test Battery (mNTB) that includes: Visual Paired Associates, Logical Memory Recall of the Wechsler Memory Scale-Revised, Rey Auditory Verbal Learning, Digit Span, Word and Category Fluency test, Trail Making Test, Letter Digit Substitution test.
次要结局
- Quality of Life Questionnaire (15D)(Up to 2 years)
- Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS-MCI-ADL)(Up to 2 years)
- Episodic Memory(Up to 2 years)
- Executive Function(Up to 2 years)
- Global Physical Activity Questionnaire (GPAQ)(Up to 2 years)
- Processing Speed(Up to 2 years)
- Changes in Lipid Profile(Up to 2 years)
- Pittsburgh Sleep Quality Index (PSQI)(Up to 2 years)
- Resource Use Inventory (RUI)(Up to 2 years)
- Hip and waist circumference(Up to 2 years)
- Changes in Blood Pressure(Up to 2 years)
- The Geriatric Depression Scale (GDS)(Up to 2 years)
- Prospective-Retrospective Memory Questionnaire(Up to 2 years)
- 36-Item Short Form Survey (SF-36)(Up to 2 years)
- Clinical Dementia Rating-Sum of Boxes (CDR-SB)(Up to 2 years)
- Physical Performance Test (PPT)(Up to 2 years)
- Neuroimaging(Up to 2 years)
- Leisure-Time Activities Questionnaire(Up to 2 years)
- Height(Up to 2 years)
- Weight(Up to 2 years)
- Changes in Glucose Regulation(Up to 2 years)
- Blood Biomarkers(Up to 2 years)
- Retinal Imaging Markers(Baseline only)
研究者
Christopher Chen Li-Hsian
Associate Professor
National University of Singapore