The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study
- Conditions
- Cognitive ImpairmentNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisorderAlzheimer DiseaseDementiaNervous System DiseasesVascular Cognitive Impairment
- Interventions
- Behavioral: Self-Guided InterventionBehavioral: Structured Lifestyle Intervention
- Registration Number
- NCT05007353
- Lead Sponsor
- National University of Singapore
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- Age 60-77 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
- malignant diseases
- dementia
- substantial cognitive decline (MoCA<18)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-Guided Intervention Self-Guided Intervention General health information provided to participants. Structured Lifestyle Intervention Structured Lifestyle Intervention Structured lifestyle modification program developed for participants targeting diet, physical exercise, cognitive training, and social stimulation.
- Primary Outcome Measures
Name Time Method Global Cognition 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.
- Secondary Outcome Measures
Name Time Method Height Up to 2 years Height is measured in metres.
Executive Function Up to 2 years Executive function measured using mNTB subtests: Digit Span, Word and Category Fluency test, Trail Making Test Part B.
Global Physical Activity Questionnaire (GPAQ) Up to 2 years 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'.
Changes in Lipid Profile Up to 2 years Vascular and metabolic risk factors measured by changes in lipid profile in mmol/L.
Pittsburgh Sleep Quality Index (PSQI) Up to 2 years The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Resource Use Inventory (RUI) Up to 2 years 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.
Hip and waist circumference Up to 2 years Hip and waist circumference measured in centimetres.
Changes in Blood Pressure Up to 2 years Vascular and metabolic risk factors measured by changes in blood pressure in mmHg. Incident events using serious adverse event reports will also be assessed.
The Geriatric Depression Scale (GDS) Up to 2 years 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.
Prospective-Retrospective Memory Questionnaire Up to 2 years The Prospective-Retrospective Memory Questionnaire (PRMQ) is measured on a 5-point scale. Higher scores represent greater frequency of memory failures.
36-Item Short Form Survey (SF-36) Up to 2 years 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.
Clinical Dementia Rating-Sum of Boxes (CDR-SB) Up to 2 years The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
Physical Performance Test (PPT) Up to 2 years The Physical Performance Test (PPT) is scored from 0 to 36. Higher scores represent better performance.
Neuroimaging Up to 2 years 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.
Episodic Memory Up to 2 years 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.
Processing Speed Up to 2 years Processing speed measured using mNTB subtests: Letter Digit Substitution test and Trail-Making Test Part A.
Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS-MCI-ADL) Up to 2 years 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.
Quality of Life Questionnaire (15D) Up to 2 years 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.
Leisure-Time Activities Questionnaire Up to 2 years 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.
Weight Up to 2 years Weight is measured in kilograms.
Changes in Glucose Regulation Up to 2 years Vascular and metabolic risk factors measured by changes in glucose regulation in mmol/L.
Blood Biomarkers Up to 2 years 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.
Retinal Imaging Markers Baseline only Multimodal retinal imaging will be used to assess retinal structural, vascular and neuronal changes.
Trial Locations
- Locations (3)
National University Hospital
🇸🇬Singapore, Singapore
National University of Singapore, Yong Loo Lin School of Medicine
🇸🇬Singapore, Singapore
National Neuroscience Institute @ Tan Tock Seng Campus (NNI @ TTSH campus)
🇸🇬Singapore, Singapore