Successful Aging and Age-related Decline

Not Applicable

Recruiting

• Conditions: Elderly; Physical Decline; Aging; Cognitive Decline; Intervention Study

• Registration Number: NCT06376656
• Lead Sponsor: Sunway University

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.

Study Timeline

• Study Start: 2022-05-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Primary Completion: 2029-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in levels of human salivary lactoferrin	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.
Cost-benefit analysis of intervention	4 years	The economic benefits from the interventions will be evaluated and will cover three aspects: financial, productivity and health.
Changes in cognitive scores	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.
Changes in electroencephalogram (EEG)	4 years	Onset of neural responses to errors in the Go/No Go task will be evaluated using EEG.
Changes in levels of human salivary C-reactive proteins	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.
Changes in structural magnetic resonance imaging (MRI)	4 years	Relationship between Wisconsin Card Sorting Test performance and grey matter volume will be evaluated using structural MRI.
Changes in salivary telomere length	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 Outcome Measures

Name	Time	Method
Changes in anxiety scores	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.
Changes in depression scores	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.

Trial Locations

Locations (1)

Sunway University; 🇲🇾 Petaling Jaya, Selangor, Malaysia