- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440969
Evaluation of Pilot Community-based Multi-domain Program Older Adults at Risk of Cognitive Impairment
Dementia - Early Detection and Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Older people like to continue to think clearly, remember accurately, and make good decisions. The loss of the ability to live independently is one of the greatest fears adults express when considering old age. As physical fitness declines, the brain also ages. While cognition in areas related to wisdom and experience improve in older adults, others like memory, attention, and reaction time can decline and affect daily life. As life expectancy increases, maintaining cognition is critical to productive and healthy aging. Older adults want to continue to negotiate the environment, perform routine tasks (e.g. driving), learn new things, and live independently. Cognitive impairment creates significant challenges for individuals, their families and friends, and clinicians who provide their health care. Furthermore, available research indicates that cognitive impairment is not detected in substantial proportions of older people in primary care who have the condition. Early detection allows for earlier diagnosis and appropriate intervention, education, psycho-social support, and engagement in shared decision-making regarding life planning, financial matters, and health care. Based on this, there is a need for scalable, implementable intervention programmes which can be introduced in the community.
Previous studies have corroborated the efficacy of certain aspects of training which can promote delay in cognitive decline. Specifically, these encompass nutritional, cognitive and physical activity. Individually, these components have been extensively validated and proven effective in negating cognitive decline. However, little attempts have been made to evaluate the effectiveness and feasibility of combining these components into a multi-modal program. The only preceding study to have proven efficacy of multi-modal programs in improving cognition was carried out in the FINGER trial. However, to date, no similar studies have been carried out locally. Therefore, this study aims to address these questions; by using a mixed method approach; combining both qualitative and quantitative methods to assess the achievability of such a programme.
The programme aims to identify individuals at risk of cognitive decline and is offered to ensure intervention measures are adopted at early stages. The multi-domain program comprises a combination of nutritional guidance, group physical activity and cognitive training segments; all of which are individually regarded as proven interventions for cognitive impairment. The program will be coordinated between three commercial entities, Holmusk, Neeuro and ProAge and is funded by the National Innovation Challenge (NIC), MOH, Singapore. As part of the programme, the investigators will be utilizing a locally developed risk score created from the Singapore Longitudinal Aging study (SLAS), that can be widely administered and is applicable to the local population. Therefore, the study aims to use a mixed methods approach to evaluate:
- The feasibility and sustainability of implementing the programme, which will be assessed based on several considerations such as reach, implementation and maintenance or areas of improvement.
- The effectiveness of the programme on cognitive decline and improvement in fitness and nutrition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 768024
- Geriatric Education and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks.
(Week 1 - 24)
|
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. |
EXPERIMENTAL: Wait-list control
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)
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in cognition at Week 12 and Week 48
Time Frame: Baseline, Week 24 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in quality of life at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
|
Quality of Life Questionnaire (EuroQol EQ-5D-5L) index measures participants' perception of their ability to 1) self-care, 2) carry out usual activities, and their levels of 3) mobility, 4) pain/discomfort, and 5) anxiety/depression.
The EQ-5D index is derived by combining responses from these 5 categories.
A higher index indicates higher quality of life.
EQ-5D Visual Analogue Scale (VAS) is a 0 - 100 scale that measures participants' perception of their health status on the day this scale was used, with 100 signifying the best possible state of health.
|
Baseline, Week 24 and Week 48
|
Change from baseline in aerobic strength at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
|
Two-minute step test is a test of aerobic endurance, where participants are required to take as many steps (marching on the spot) as possible in two minutes.
|
Baseline, Week 24 and Week 48
|
Change from baseline in leg strength at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
|
Chair stand is a test of leg strength where participants are required to stand up from seated position as many times as possible in thirty seconds
|
Baseline, Week 24 and Week 48
|
Change from baseline in arm strength at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
|
Handgrip strength is a test of hand and forearm muscular strength, where participants are required to squeeze a dynamometer as hard as possible.
Units are measured in kilogrammes.
|
Baseline, Week 24 and Week 48
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in blood lipid levels at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
|
Fasting blood sample collected via fingerprick to measure blood lipid levels on a rapid blood kit (Cholesh LDX, Abbott, IL, U.S)
|
Baseline, Week 24 and Week 48
|
Evaluation questionnaire
Time Frame: Week 24 and Week 48
|
The questionnaire is to address some points of the REAIM framework, which stands for Reach, Effectiveness, Adoption, Implementation and Maintenance. Questions are either delivered on a 5-point Likert Scale for quantitative analysis (e.g.Did you find the exercises easy to follow? 1 - Extremely difficult, 2 - Quite difficult, 3 - Neutral, 4 - Quite easy, 5 - Extremely easy or as open ended questions for qualitative analysis (e.g. Are there barriers that will prevent you from taking up the programme?) Questionnaires are delivered to participants, centre managers and implementation partners. |
Week 24 and Week 48
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GERI1613
- MOH/NIC/COG02/2017 (OTHER_GRANT: MOH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Decline
-
Jean-François DémonetUniversity of Lausanne HospitalsActive, not recruitingCognitive Performance | Functional Capacity | Subjective Cognitive Decline | Age-related Cognitive DeclineSwitzerland
-
Rotman Research Institute at BaycrestSunnybrook Health Sciences Centre; University of Waterloo; Toronto Rehabilitation... and other collaboratorsTerminatedSubjective Cognitive Decline | Age-Related Cognitive DeclineCanada
-
National Taiwan University HospitalNational Taiwan Science Education Center(NTSEC)RecruitingCognitive Training | Subjective Cognitive DeclineTaiwan
-
Sahmyook UniversityCompletedCognition Disorders in Old Age | Subjective Memory Decline | Cognitive Decline, MildKorea, Republic of
-
University of Milano BicoccaRecruitingMild Cognitive Impairment | Subjective Cognitive DeclineItaly
-
Beijing Hospital of Traditional Chinese MedicineUnknownSubjective Cognitive Decline | Subjective Cognitive ComplaintChina
-
BaycrestCompletedSubjective Cognitive DeclineCanada
-
Evidation HealthNeurotrackCompleted
-
Fundacion Clinic per a la Recerca BiomédicaUnknownSubjective Cognitive Decline
-
Vanderbilt University Medical CenterRecruiting
Clinical Trials on Multi-domain intervention
-
National Yang Ming UniversityCompleted
-
National Yang Ming UniversityNational Science and Technology CouncilCompletedAge-related Cognitive Decline | Age-related Physiology DeclineTaiwan
-
NeurocoreCompletedMild Cognitive ImpairmentUnited States
-
Consorzio Futuro in RicercaUniversità degli Studi di Ferrara; Abbott Medical DevicesRecruitingCoronary Artery Disease | Microvascular Angina | Microvascular Ischemia of MyocardiumItaly
-
University Hospital of FerraraAzienda Usl di Bologna; Azienda Unità Sanitaria Locale di PiacenzaActive, not recruitingMyocardial Infarction | AgingItaly
-
Wake Forest University Health SciencesNational Institute on Aging (NIA)CompletedAcute Decompensated Heart FailureUnited States
-
Zhejiang UniversityRecruitingBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Neurocognitive Disorders | Cognitive Impairment | Alzheimer Disease | Mental Disorder | Cognition Disorder | Vascular Cognitive Impairment | DementChina
-
University of Milano BicoccaCompletedAge-related Cognitive DeclineItaly
-
Beijing Anzhen HospitalBeijing Wispirit Technology Co., LtdActive, not recruitingCoronary Heart Disease | Mild Cognitive ImpairmentChina
-
IRCCS Fondazione Stella MarisUniversity of Pisa; The University of Queensland; University of Castilla-La Mancha and other collaboratorsNot yet recruitingUnilateral Cerebral PalsyItaly, Spain