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Active, Not Recruiting

NCT Number: NCT06376656

Successful Aging and Age-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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging Anxiety Disorders Behavior Behavioral Symptoms Cognition Disorders Cognitive Decline Cognitive Dysfunction Depression Elderly Intervention Study Mental Disorders Motor Activity Neurocognitive Disorders Physical Decline

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunway University

Petaling Jaya, Selangor, 47500, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

  • 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.

Treatment and study plan

Cognitive stimulation

Behavioral

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 activity

Behavioral

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.

Primary outcomes

  1. Changes in cognitive scores

    Time frame: 4 years

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

  2. Changes in electroencephalogram (EEG)

    Time frame: 4 years

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

  3. Changes in structural magnetic resonance imaging (MRI)

    Time frame: 4 years

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

  4. Cost-benefit analysis of intervention

    Time frame: 4 years

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

  5. Changes in levels of human salivary lactoferrin

    Time frame: 4 years

    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.

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

    Time frame: 4 years

    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.

  7. Changes in salivary telomere length

    Time frame: 4 years

    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.

Secondary outcomes

  1. Changes in depression scores

    Time frame: 4 years

    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.

  2. Changes in anxiety scores

    Time frame: 4 years

    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.

  3. Changes in body composition

    Time frame: Throughout study participation, up to 4 years

    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.

  4. Changes in Body Mass Index (BMI)

    Time frame: Throughout study participation, up to 4 years

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

  5. Changes in blood pressure

    Time frame: Throughout study participation, up to 4 years

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

  6. Changes in falls risk

    Time frame: Throughout study participation, up to 4 years

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

  7. Changes in sarcopenia risk

    Time frame: Throughout study participation, up to 4 years

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

  8. Changes in frailty status

    Time frame: Throughout study participation, up to 4 years

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

Sponsors and collaborators

Lead sponsor

Sunway University

Other

Registry information

Official study title

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

Acronym: MyAgeWell

Important dates

Study start
2022
Primary completion
2029
Study completion
2030
First posted
Apr 19, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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