- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06376656
Successful Aging and Age-related Decline (MyAgeWell)
Successful Ageing: Evidence-based Interventions to Delay Ageing-related Decline
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Petaling Jaya, Selangor, Malaysia, 47500
- Sunway University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive stimulation
Participants will take part in psychoeducation, videogaming, book club and technology training workshops.
|
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. |
|
Experimental: Physical activity
Participants will take part in walking, Zumba, resistance exercise and aerobics sessions.
|
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. |
|
Experimental: Combined intervention
Participants will take part in both cognitive stimulation and physical activity intervention sessions.
|
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. 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. |
|
No Intervention: Non-intervention control
Participants will not take part in any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 years
|
|
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.
|
4 years
|
|
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 years
|
|
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.
|
4 years
|
|
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.
|
4 years
|
|
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.
|
4 years
|
|
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.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 years
|
|
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.
|
4 years
|
|
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.
|
Throughout study participation, up to 4 years
|
|
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.
|
Throughout study participation, up to 4 years
|
|
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.
|
Throughout study participation, up to 4 years
|
|
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.
|
Throughout study participation, up to 4 years
|
|
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.
|
Throughout study participation, up to 4 years
|
|
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.
|
Throughout study participation, up to 4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yook Chin Chia Professor, Datin, Dr, MBBS, FRCP, Sunway University
- Study Chair: Tin Tin Su, Monash University
- Study Chair: Rozainee Khairudin, The National University of Malaysia
- Study Chair: Nur Ain Shahrier, Sunway University
- Study Chair: Audrey Wei Ling Lim, Sunway University
Publications and helpful links
General Publications
- 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.
- 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.
- Murman DL. The Impact of Age on Cognition. Semin Hear. 2015 Aug;36(3):111-21. doi: 10.1055/s-0035-1555115.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LRGS/1/2019/SYUC/02/1
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.
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