NCT04440969

Brief Summary

The multi-domain programme was adapted from a larger international multi-domain interventional study for the Singapore community of older adults at risk of cognitive impairment. This programme comprises nutritional, physical and cognitive components delivered by implementation partners in the community. A dementia risk screening tool developed from the Singapore Longitudinal Ageing Study (SLAS) data was used to screen potential participants. The nutritional component includes nutrition guidance via a nutritional app, while cognition component involves computerised training on a touch screen device and physical aspects involves dual-task exercises.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

June 16, 2020

Last Update Submit

June 18, 2020

Conditions

Cognitive DeclineCognitive Impairment, Mild

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cognition at Week 12 and Week 48

    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a cognitive test that consists of 12 subtests grouped into five domains - immediate and delayed memory, visuospatial/construction, language and attention. A higher score indicates better cognitive performance.

    Baseline, Week 24 and Week 48

Secondary Outcomes (4)

  • Change from baseline in quality of life at Week 12 and Week 48

    Baseline, Week 24 and Week 48

  • Change from baseline in aerobic strength at Week 12 and Week 48

    Baseline, Week 24 and Week 48

  • Change from baseline in leg strength at Week 12 and Week 48

    Baseline, Week 24 and Week 48

  • Change from baseline in arm strength at Week 12 and Week 48

    Baseline, Week 24 and Week 48

Other Outcomes (2)

  • Change from baseline in blood lipid levels at Week 12 and Week 48

    Baseline, Week 24 and Week 48

  • Evaluation questionnaire

    Week 24 and Week 48

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks. (Week 1 - 24)

Behavioral: Multi-domain intervention

Wait-list control

EXPERIMENTAL

Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks after Intervention Group has completed intervention. (Week 25 - 48)

Behavioral: Multi-domain intervention

Interventions

Multi-domain interventionBEHAVIORAL

Participants will undergo dual-task physical exercises and small group activities comprising of quizzes, puzzles and simulate daily living activities that have been gamified (Mindfun and MindGym, ProAge,Singapore). They will also play games on a touch screen device (computerised cognitive training) that aims to improve cognition in the domains of attention, memory, spatial ability, decision making and cognitive flexibility (Memorie, Neeuro, Singapore) while wearing the Senzeband, which emits low frequency signals on the forehead picked up by four individual sensors, allowing participant to play certain games without touching the device but by attention and focus (https://www.neeuro.com/senzeband). Dietary guidance will be delivered via a dietary app (Glycoleap). Participants are expected to take photos of their meals daily and upload them onto the app. Certified dieticians will give advice and tips on their choice of food and how to make healthier choices through the app.

InterventionWait-list control

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 55 years of age
  • Interested \& willing to participate in a lifestyle \& cognition training programme
  • Residing in Singapore over the next 1 year
  • Have a risk score of more than 6-8, implying a 10-20% risk of developing cognitive decline over the next 5 years

You may not qualify if:

  • Diagnosed with cognitive disorders such as mild cognitive impairment, dementia or Parkinson's Disease
  • Wheelchair bound
  • Total hearing or visual impairment
  • Medical instructions prohibiting participation in the programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Education And Research Institute

Singapore, 768024, Singapore

Location

Related Publications (8)

  • Lustig C, Shah P, Seidler R, Reuter-Lorenz PA. Aging, training, and the brain: a review and future directions. Neuropsychol Rev. 2009 Dec;19(4):504-22. doi: 10.1007/s11065-009-9119-9. Epub 2009 Oct 30.

    PMID: 19876740BACKGROUND

  • Morley JE, Morris JC, Berg-Weger M, Borson S, Carpenter BD, Del Campo N, Dubois B, Fargo K, Fitten LJ, Flaherty JH, Ganguli M, Grossberg GT, Malmstrom TK, Petersen RD, Rodriguez C, Saykin AJ, Scheltens P, Tangalos EG, Verghese J, Wilcock G, Winblad B, Woo J, Vellas B. Brain health: the importance of recognizing cognitive impairment: an IAGG consensus conference. J Am Med Dir Assoc. 2015 Sep 1;16(9):731-9. doi: 10.1016/j.jamda.2015.06.017.

    PMID: 26315321BACKGROUND

  • Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.

    PMID: 21878600BACKGROUND

  • Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.

    PMID: 23332672BACKGROUND

  • 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: 25771249BACKGROUND

  • Smith PJ, Blumenthal JA. Diet and neurocognition: review of evidence and methodological considerations. Curr Aging Sci. 2010 Feb;3(1):57-66. doi: 10.2174/1874609811003010057.

    PMID: 20298171BACKGROUND

  • Rawtaer I, Feng L, Yuen VH, Li J, Chong MS, Lim WS, Lee TS, Qiu C, Feng L, Kua EH, Ng TP. A Risk Score for the Prediction of Neurocognitive Disorders among Community-Dwelling Chinese Older Adults. Dement Geriatr Cogn Disord. 2016;41(5-6):348-58. doi: 10.1159/000447448. Epub 2016 Jul 20.

    PMID: 27433801BACKGROUND

  • Ng PEM, Nicholas SO, Wee SL, Yau TY, Chan A, Chng I, Yap LKP, Ng TP. Implementation and effectiveness of a multi-domain program for older adults at risk of cognitive impairment at neighborhood senior centres. Sci Rep. 2021 Feb 15;11(1):3787. doi: 10.1038/s41598-021-83408-5.

    PMID: 33589714DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Shiou Liang Wee, PhD

    Geriatric Education and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 22, 2020

Study Start

June 20, 2018

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Due to confidentiality issues, individual participant data will not be made public but de-identified data can be obtained upon request.

Locations

SG(1)