ClinicalTrials.gg
Active, not recruitingNCT06376656MyAgeWellUpdated May 12, 2026

Successful Aging and Age-related Decline

An interventional study of Cognitive stimulation and Physical activity in Aging, Elderly and Cognitive Decline, sponsored by Sunway University. Active, not recruiting at 1 site in Malaysia. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Sunway University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled May 2022, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

Recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. The investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline.

Read the detailed description

This is a longitudinal, controlled, cohort study. The overarching aim in this intervention study is three-fold: (1) to test hypotheses derived from ageing-related theories, (2) to provide robust measurable evidence both in the long-term and validate meaningful interventions, and (3) provide quantifiable cost-benefit ratio to suggested solutions. A cohort of Malaysian older adults will be recruited and assigned to one of the groups, either cognitive stimulation, physical activity, combined cognitive stimulation and physical activity, or non-intervention control.

02

Conditions studied

  • Aging
  • Elderly
  • Cognitive Decline
  • Physical Decline
  • Intervention Study

Keywords

  • Cognition
  • Physical Activity
  • Biological Aging
  • Intervention
  • Neuroscience
  • MRI
  • EEG
  • Biological Markers
  • Cost-benefit Analysis
  • Age-related Decline
  • Depression
  • Anxiety
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 400 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Sunway University is the lead sponsor of 11 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Malaysian older adults aged 60 and above who fulfil the following criteria will be recruited:

Inclusion criteria

Inclusion Criteria:

  • Healthy and this includes those seeking regular medical attention,
  • Have some form of mobility (ability to walk short distances at least 3m),
  • Able to communicate in at least one of the following languages: English, Malay, Mandarin, Tamil.

Exclusion criteria

Exclusion Criteria:

  • Older adults with a history of stroke,
  • Diagnosis of neurodegenerative diseases (such as Alzheimer's disease or Parkinson's) or psychiatric disorders,
  • Uncorrected auditory and/or visual impairments,
  • Currently on psychiatric medications,
  • Immobile,
  • Require full-time caregiver assistance,
  • With comprehension impediments from the assessment portion of this project,
  • A (MoCA) score of \<13.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Cognitive stimulation

    Participants will take part in psychoeducation, videogaming, book club and technology training workshops.

    Behavioral: Cognitive stimulation

  • Experimental
    Physical activity

    Participants will take part in walking, Zumba, resistance exercise and aerobics sessions.

    Behavioral: Physical activity

  • Experimental
    Combined intervention

    Participants will take part in both cognitive stimulation and physical activity intervention sessions.

    Behavioral: Cognitive stimulation · Behavioral: Physical activity

  • No intervention
    Non-intervention control

    Participants will not take part in any intervention.

Interventions

  • BehavioralCognitive stimulation

    The cognitive stimulation will comprise of psychoeducation, videogaming, book club and technology training workshop sessions. Participants will take part in weekly sessions that are an hour long each. For every six months, the participants will alternate between psychoeducation, videogaming, book club and technology training workshop sessions.

  • BehavioralPhysical activity

    The physical activity intervention will comprise of walking, Zumba, resistance exercise and aerobics sessions. Participants will take part in weekly sessions that are an hour long each. For every six months, the participants will alternate between walking, Zumba, resistance exercise and aerobics sessions until the end of intervention period.

06

What researchers measure

Primary outcomes

  1. Changes in cognitive scores

    Changes in cognitive scores will be evaluated using Montreal Cognitive Assessment (MoCA). Possible scores range from 0-30. Higher scores indicate less cognitive impairment.

    Time frame: 4 years

  2. Changes in electroencephalogram (EEG)

    Onset of neural responses to errors in the Go/No Go task will be evaluated using EEG.

    Time frame: 4 years

  3. Changes in structural magnetic resonance imaging (MRI)

    Relationship between Wisconsin Card Sorting Test performance and grey matter volume will be evaluated using structural MRI.

    Time frame: 4 years

  4. Cost-benefit analysis of intervention

    The economic benefits from the interventions will be evaluated and will cover three aspects: financial, productivity and health.

    Time frame: 4 years

  5. Changes in levels of human salivary lactoferrin

    Changes in levels of human salivary lactoferrin (ng/mL) will be measured using salivary Enzyme-Linked Immunosorbent Assay (ELISA) kits. Low levels of lactoferrin can potentially indicate higher risk for cognitive impairment.

    Time frame: 4 years

  6. Changes in levels of human salivary C-reactive proteins

    Changes in levels of human salivary C-reactive proteins (CRP, mg/L) will be measured using salivary Enzyme-Linked Immunosorbent Assay (ELISA) kits. High levels of CRP can indicate inflammation and its association with greater cognitive decline.

    Time frame: 4 years

  7. Changes in salivary telomere length

    Changes in salivary telomere length (T/S ratio) will be measured using quantitative PCR. A higher T/S ratio indicates better preservation of telomere length hence better preservation of cognition.

    Time frame: 4 years

Secondary outcomes

  1. Changes in depression scores

    Changes in depression scores will be measured using part of the Center for Epidemiologic Studies Depression Scale (CES-D). Possible scores range from 0-42. Higher scores indicating greater frequency of depressive experiences.

    Time frame: 4 years

  2. Changes in anxiety scores

    Changes in anxiety scores will be measured using part of the Form Y of the State-Trait Anxiety Inventory (STAI). Possible scores range from 6-24. Higher scores indicate greater anxiety.

    Time frame: 4 years

  3. Changes in body composition

    Changes in body composition will be measured using Bioelectrical Impedance Analysis (BIA), including parameters such as body fat percentage, muscle mass and visceral fat composition.

    Time frame: Throughout study participation, up to 4 years

  4. Changes in Body Mass Index (BMI)

    Changes in Body Mass Index (BMI, kg/m²) will be evaluated using participants' height and body weight measurements.

    Time frame: Throughout study participation, up to 4 years

  5. Changes in blood pressure

    Changes in systolic and diastolic blood pressure (mmHg) will be measured using a standard blood pressure monitoring device.

    Time frame: Throughout study participation, up to 4 years

  6. Changes in falls risk

    Changes in falls risk will be evaluated using the Falls Risk Assessment Tool (FRAT). Higher scores indicate greater risk of falls.

    Time frame: Throughout study participation, up to 4 years

  7. Changes in sarcopenia risk

    Changes in sarcopenia risk will be evaluated using the SARC-F questionnaire. Higher scores indicate greater risk of sarcopenia.

    Time frame: Throughout study participation, up to 4 years

  8. Changes in frailty status

    Changes in frailty status will be assessed using the Pictorial Fit-Frail Scale. Higher scores indicate greater frailty.

    Time frame: Throughout study participation, up to 4 years

07

Study locations

1 site
08

References and documents

Publications

  • Bogataj S, Mesaric KK, Pajek M, Petrusic T, Pajek J. Physical exercise and cognitive training interventions to improve cognition in hemodialysis patients: A systematic review. Front Public Health. 2022 Oct 14;10:1032076. doi: 10.3389/fpubh.2022.1032076. eCollection 2022. PubMed 36311587 ↗
  • Erickson KI, Leckie RL, Weinstein AM. Physical activity, fitness, and gray matter volume. Neurobiol Aging. 2014 Sep;35 Suppl 2:S20-8. doi: 10.1016/j.neurobiolaging.2014.03.034. Epub 2014 May 14. PubMed 24952993 ↗
  • Murman DL. The Impact of Age on Cognition. Semin Hear. 2015 Aug;36(3):111-21. doi: 10.1055/s-0035-1555115. PubMed 27516712 ↗
  • Ogawa T, Hirose Y, Honda-Ogawa M, Sugimoto M, Sasaki S, Kibi M, Kawabata S, Ikebe K, Maeda Y. Composition of salivary microbiota in elderly subjects. Sci Rep. 2018 Jan 11;8(1):414. doi: 10.1038/s41598-017-18677-0. PubMed 29323208 ↗
  • Wells PM, Sprockett DD, Bowyer RCE, Kurushima Y, Relman DA, Williams FMK, Steves CJ. Influential factors of saliva microbiota composition. Sci Rep. 2022 Nov 7;12(1):18894. doi: 10.1038/s41598-022-23266-x. PubMed 36344584 ↗
  • Yong MH, Lawrie L, Schaefer A, Phillips LH. The Effects of Adult Aging and Culture on Theory of Mind. J Gerontol B Psychol Sci Soc Sci. 2022 Feb 3;77(2):332-340. doi: 10.1093/geronb/gbab093. PubMed 34036302 ↗
  • Chia YC, Low END, Jenkins M, Lee YL, Su TT, Khairudin R, Salehuddin K, Vaithilingam S, Chew J, Lim WL, Yong MH, Schaefer A. An Evidence-Based Cognitive Stimulation and Physical Activity Intervention to Delay Aging-Related Decline: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 8;15:e88268. doi: 10.2196/88268. PubMed 42417457 ↗

Individual participant data

Plan to share: No — No. However, limited access to data could be shared upon reasonable request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Aug 2029, 87 months after the start.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 87 months is above that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2024
First posted
Apr 19, 2024
StartActual
May 20, 2022
Primary completionEst.
Aug 31, 2029
CompletionEst.
Aug 31, 2030
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06376656
Lead sponsor
Sunway University
Responsible party
YookChin Chia (Professor, Head of Department of Medical Sciences, School of Medical and Life Sciences and Programme Leader of Postgraduate Diploma In Primary Care For Elderly, Sunway University) — Principal investigator
First posted
Apr 19, 2024
Start date
May 20, 2022
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
May 12, 2026

Study contacts

Yook Chin Chia Professor, Datin, Dr, MBBS, FRCP
principal investigator · Sunway University
Tin Tin Su
study chair · Monash University
Rozainee Khairudin
study chair · The National University of Malaysia
Nur Ain Shahrier
study chair · Sunway University
Audrey Wei Ling Lim
study chair · Sunway University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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