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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,200
Structured Lifestyle Intervention (SLI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors.
In the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided.
National University Hospital
Singapore, Singapore
RECRUITINGNational University of Singapore, Yong Loo Lin School of Medicine
Singapore, Singapore
RECRUITINGNational Neuroscience Institute @ Tan Tock Seng Campus (NNI @ TTSH campus)
Singapore, Singapore
NOT_YET_RECRUITINGGlobal Cognition
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.
Time frame: Up to 2 years
Episodic Memory
Episodic memory measured using mNTB subtests: Visual paired associates tests, Logical Memory immediate and delayed recall of the Wechsler Memory Scale-Revised, Rey Auditory Verbal Learning test.
Time frame: Up to 2 years
Executive Function
Executive function measured using mNTB subtests: Digit Span, Word and Category Fluency test, Trail Making Test Part B.
Time frame: Up to 2 years
Processing Speed
Processing speed measured using mNTB subtests: Letter Digit Substitution test and Trail-Making Test Part A.
Time frame: Up to 2 years
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
Time frame: Up to 2 years
Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS-MCI-ADL)
The Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS-MCI-ADL) is scored from 0 to 53. Higher scores reflect better performance.
Time frame: Up to 2 years
The Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) is scored from 0 to 15. Scores of 0-4 are considered normal, 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time frame: Up to 2 years
Global Physical Activity Questionnaire (GPAQ)
The Global Physical Activity Questionnaire (GPAQ) measures physical activity across 3 domains: work, travel, and recreation, as well as average time per day spent in sedentary behavior. The GPAQ is scored based on a population's mean or median physical activity spent in physical activity or by classifying a certain percentage of a population as 'inactive' or 'insufficiently active'.
Time frame: Up to 2 years
Prospective-Retrospective Memory Questionnaire
The Prospective-Retrospective Memory Questionnaire (PRMQ) is measured on a 5-point scale. Higher scores represent greater frequency of memory failures.
Time frame: Up to 2 years
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Time frame: Up to 2 years
Leisure-Time Activities Questionnaire
The Leisure-Time Activities Questionnaire measures the frequency of engagement in the following activities: Health activities, Social activities, Productive activities, Fitness activities, Recreational activities, Any cognitively-stimulating activities. Scores are measured on a 3-point scale. Higher scores represent higher frequency of engagement in leisure-time activities.
Time frame: Up to 2 years
Physical Performance Test (PPT)
The Physical Performance Test (PPT) is scored from 0 to 36. Higher scores represent better performance.
Time frame: Up to 2 years
Quality of Life Questionnaire (15D)
The Quality of Life Questionnaire (15D) has a single index (15D score) on a 0-1 scale, which represents overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL). This is calculated from the health state descriptive system by using a set of population-based preference or utility weights.
Time frame: Up to 2 years
36-Item Short Form Survey (SF-36)
The 36-Item Short Form Survey (SF-36) has eight domains. Each domain is scored from 0 to 100. Higher scores represent a more favourable health state.
Time frame: Up to 2 years
Resource Use Inventory (RUI)
The Resource Use Inventory (RUI) measures 4 domains: direct medical care, direct nonmedical care, informal care, and subjects' time use. The RUI is filled in based on the frequency and amount of resources used. If none were used, '00' is entered.
Time frame: Up to 2 years
Height
Height is measured in metres.
Time frame: Up to 2 years
Weight
Weight is measured in kilograms.
Time frame: Up to 2 years
Hip and waist circumference
Hip and waist circumference measured in centimetres.
Time frame: Up to 2 years
Changes in Blood Pressure
Vascular and metabolic risk factors measured by changes in blood pressure in mmHg. Incident events using serious adverse event reports will also be assessed.
Time frame: Up to 2 years
Changes in Lipid Profile
Vascular and metabolic risk factors measured by changes in lipid profile in mmol/L.
Time frame: Up to 2 years
Changes in Glucose Regulation
Vascular and metabolic risk factors measured by changes in glucose regulation in mmol/L.
Time frame: Up to 2 years
Neuroimaging
Magnetic Resonance Imaging will be used to assess changes in brain structural integrity, grey matter volume loss, white matter microstructure degradation, and increase of cerebrovascular disease markers (CeVD). Vascular polygenic risk scores (PRS) and its association with neurodegeneration, CeVD burden and cognitive decline will be performed.
Time frame: Up to 2 years
Blood Biomarkers
Novel and accessible blood markers to monitor AD- and CeVD-associated pathologies will be measured. Plasma concentrations of cardiac markers (High-sensitive cardiac troponin T (hs Troponin T), N-terminal pro b-type natriuretic peptide (NT-proBNP) and Growth/differentiation factor 15 (GDF 15)), and peripheral biomarkers of Aβ, tau and synaptic pathology, oxidative stress, endothelial/cardiovascular injury and degenerative protein modifications (DPMs) damaged proteins will be used.
Time frame: Up to 2 years
Retinal Imaging Markers
Multimodal retinal imaging will be used to assess retinal structural, vascular and neuronal changes.
Time frame: Baseline only
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