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AgingMyAgeWellNCT06376656

Successful Aging and Age-related Decline

A study testing Cognitive stimulation and Physical activity in people with Aging and Elderly, run by Sunway University at 1 site in Malaysia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Elderly, Cognitive Decline
What is being tested?
Cognitive stimulation and Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteMalaysia
Study dates
20 May 2022to 31 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 Montreal Cognitive Assessment (MoCA) score of <13.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Sunway University

    Petaling Jaya, Selangor, 47500

Other trials in Malaysia

About this study

Official title: Successful Ageing: Evidence-based Interventions to Delay Ageing-related Decline

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.

Being tested
Cognitive stimulation, Physical activity
Keywords
Cognition, Physical Activity, Biological Aging, Intervention, Neuroscience, MRI, EEG, Biological Markers, Cost-benefit Analysis, Age-related Decline, Depression, Anxiety
Medical subject headings
Cognitive Dysfunction, Motor Activity, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive stimulationBehavioural

    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.

  • Physical activityBehavioural

    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.

Study groups in NCT06376656
Study groupRoleWhat they receive
Cognitive stimulationExperimentalParticipants will take part in psychoeducation, videogaming, book club and technology training workshops.
Receives: Behavioral: Cognitive stimulation
Physical activityExperimentalParticipants will take part in walking, Zumba, resistance exercise and aerobics sessions.
Receives: Behavioral: Physical activity
Combined interventionExperimentalParticipants will take part in both cognitive stimulation and physical activity intervention sessions.
Receives: Behavioral: Cognitive stimulation; Behavioral: Physical activity
Non-intervention controlNo interventionParticipants will not take part in any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 years

  2. Changes in electroencephalogram (EEG)

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 4 years

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Throughout study participation, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study start20 May 2022
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A cohort of older Malaysian 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.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376656
Sponsor's protocol ID
LRGS/1/2019/SYUC/02/1
Acronym
MyAgeWell
Status last verified
May 2026
First submitted
3 Apr 2024
Last updated
12 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No. However, limited access to data could be shared upon reasonable request.

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

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive stimulation and Physical activity in people with Aging and Elderly, run by Sunway University at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in cognitive scores (time frame: 4 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376656, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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