Clinical trial NCT06376656: Successful Aging and Age-related Decline
Official title: Successful Ageing: Evidence-based Interventions to Delay Ageing-related Decline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Sunway University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in cognitive scores
timeFrame: 4 years
measure: Changes in electroencephalogram (EEG)
timeFrame: 4 years
measure: Changes in structural magnetic resonance imaging (MRI)
timeFrame: 4 years
measure: Cost-benefit analysis of intervention
timeFrame: 4 years
measure: Changes in levels of human salivary lactoferrin
timeFrame: 4 years
measure: Changes in levels of human salivary C-reactive proteins
timeFrame: 4 years
measure: Changes in salivary telomere length
timeFrame: 4 years
Secondary outcomes:
measure: Changes in depression scores
timeFrame: 4 years
measure: Changes in anxiety scores
timeFrame: 4 years
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Sunway University
state: Selangor
Study officials:
affiliation: Sunway University
name: Yook Chin Chia Professor, Datin, Dr, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Tin Tin Su
role: STUDY_CHAIR
affiliation: The National University of Malaysia
name: Rozainee Khairudin
role: STUDY_CHAIR
affiliation: Sunway University
name: Nur Ain Shahrier
role: STUDY_CHAIR
affiliation: Sunway University
name: Audrey Wei Ling Lim
role: STUDY_CHAIR
References:
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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.
citation: Murman DL. The Impact of Age on Cognition. Semin Hear. 2015 Aug;36(3):111-21. doi: 10.1055/s-0035-1555115.
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.
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.
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.