The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study

NCT05007353 | Unknown

• 1 other identifier: SINGER 2021
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 3

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.

Conditions

Cognitive Impairment; Alzheimer Disease; Vascular Cognitive Impairment; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorder

Keywords

cognitive decline; cognitive impairment; multi-domain lifestyle interventions; dementia; elderly

Outcome Measures

Primary Outcomes (1)

• Global 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.

  Up to 2 years

Secondary Outcomes (23)

• Episodic Memory

  Up to 2 years

• Executive Function

  Up to 2 years

• Processing Speed

  Up to 2 years

• Clinical Dementia Rating-Sum of Boxes (CDR-SB)

  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

Study Arms (2)

Structured Lifestyle Intervention

EXPERIMENTAL

Structured lifestyle modification program developed for participants targeting diet, physical exercise, cognitive training, and social stimulation.

Behavioral: Structured Lifestyle Intervention

Self-Guided Intervention

EXPERIMENTAL

General health information provided to participants.

Behavioral: Self-Guided Intervention

Interventions

Structured Lifestyle Intervention BEHAVIORAL

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.

Also known as: SLI

Structured Lifestyle Intervention

Self-Guided Intervention BEHAVIORAL

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.

Also known as: SGI

Self-Guided Intervention

Eligibility Criteria

• Age: 60 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (3)

National University Hospital

Singapore, 117600, Singapore

RECRUITING

National University of Singapore, Yong Loo Lin School of Medicine

Singapore, 117600, Singapore

RECRUITING

National Neuroscience Institute @ Tan Tock Seng Campus (NNI @ TTSH campus)

Singapore, 308433, Singapore

NOT YET RECRUITING

Related Publications (2)

• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

  PMID: 25771249 BACKGROUND

• Chew KA, Xu X, Siongco P, Villaraza S, Phua AKS, Wong ZX, Chung CY, Tang N, Chew E, Henry CJ, Koo E, Chen C. SINgapore GERiatric intervention study to reduce physical frailty and cognitive decline (SINGER)-pilot: A feasibility study. Alzheimers Dement (N Y). 2021 Mar 15;7(1):e12141. doi: 10.1002/trc2.12141. eCollection 2021.

  PMID: 33748399 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Condition Hierarchy (Ancestors)

Tauopathies; Neurodegenerative Diseases

Study Officials

• Christopher LH Chen, MD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connie KL Teo

CONTACT

(65) 6601 5668; kee_ling_teo@nuhs.edu.sg

April KS Phua

CONTACT

(65) 6601 5668; aprilphua@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 16, 2021
• Study Start: August 23, 2021
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)