Successful Aging and Age-related Decline

Aging Clinical Trial

— MyAgeWell  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06376656
• Other study ID #: LRGS/1/2019/SYUC/02/1
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: May 2030

Study information

• Verified date: April 2024
• Source: Sunway University
• Contact: Yook Chin Chia Professor, Head of Department of Medical Sciences
• Phone: +60374918622
• Email: ycchia[@]sunway.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2030
• Est. primary completion date: May 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Elderly
• Intervention Study

Intervention

Behavioral:
• Cognitive 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.
• Physical 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.

Locations

Country	Name	City	State
Malaysia	Sunway University	Petaling Jaya	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Sunway University

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

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. — View Citation

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. — View Citation

Murman DL. The Impact of Age on Cognition. Semin Hear. 2015 Aug;36(3):111-21. doi: 10.1055/s-0035-1555115. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years
Primary	Changes in electroencephalogram (EEG)	Onset of neural responses to errors in the Go/No Go task will be evaluated using EEG.	4 years
Primary	Changes in structural magnetic resonance imaging (MRI)	Relationship between Wisconsin Card Sorting Test performance and grey matter volume will be evaluated using structural MRI.	4 years
Primary	Cost-benefit analysis of intervention	The economic benefits from the interventions will be evaluated and will cover three aspects: financial, productivity and health.	4 years
Primary	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.	4 years
Primary	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.	4 years
Primary	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.	4 years
Secondary	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.	4 years
Secondary	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.	4 years