Successful Aging and Age-related Decline

NCT06376656 | Recruiting

• 1 other identifier: LRGS/1/2019/SYUC/02/1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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

• Changes in electroencephalogram (EEG)

  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)

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

  4 years

• 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

• 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

• 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

• 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 Outcomes (2)

• Changes in depression scores

  4 years

• Changes in anxiety scores

  4 years

Study Arms (4)

Cognitive stimulation

EXPERIMENTAL

Participants will take part in psychoeducation, videogaming, book club and technology training workshops.

Behavioral: Cognitive stimulation

Physical activity

EXPERIMENTAL

Participants will take part in walking, Zumba, resistance exercise and aerobics sessions.

Behavioral: Physical activity

Combined intervention

EXPERIMENTAL

Participants will take part in both cognitive stimulation and physical activity intervention sessions.

Behavioral: Cognitive stimulation; Behavioral: Physical activity

Non-intervention control

NO INTERVENTION

Participants will not take part in any intervention.

Interventions

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.

Cognitive stimulation; Combined intervention

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.

Combined intervention; Physical activity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunway University: lead

Study Sites (1)

Sunway University

Petaling Jaya, Selangor, 47500, Malaysia

RECRUITING

Related 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.

  PMID: 36311587 BACKGROUND

• 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.

  PMID: 24952993 BACKGROUND

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

  PMID: 27516712 BACKGROUND

• 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.

  PMID: 29323208 BACKGROUND

• 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.

  PMID: 36344584 BACKGROUND

• 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.

  PMID: 34036302 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity; Depression; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yook Chin Chia Professor, Datin, Dr, MBBS, FRCP

  Sunway University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Yook Chin Chia Professor, Head of Department of Medical Sciences, MBBS; FRCP

CONTACT

+60374918622; ycchia@sunway.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Department of Medical Sciences, School of Medical and Life Sciences and Programme Leader of Postgraduate Diploma In Primary Care For Elderly

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 19, 2024
• Study Start: May 20, 2022
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)