The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study, Biomarker and Health Service Research Analyses
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cognitive Impairment
- Sponsor
- National University of Singapore
- Enrollment
- 1200
- Locations
- 3
- Primary Endpoint
- Global Cognition
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Christopher Chen Li-Hsian
Associate Professor
National University of Singapore
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •malignant diseases
- •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
Outcomes
Primary Outcomes
Global Cognition
Time Frame: 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 Outcomes
- Executive Function(Up to 2 years)
- Global Physical Activity Questionnaire (GPAQ)(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)
- Episodic Memory(Up to 2 years)
- Processing Speed(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)
- Quality of Life Questionnaire (15D)(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)