Successful Aging and Age-related Decline

Not Applicable

Recruiting

• Conditions: Elderly; Physical Decline; Aging; Cognitive Decline; Intervention Study
• Interventions: Behavioral: Physical activity; Behavioral: Cognitive stimulation

• 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

Arm && Interventions

Group	Intervention	Description
Physical activity	Physical activity	Participants will take part in walking, Zumba, resistance exercise and aerobics sessions.
Cognitive stimulation	Cognitive stimulation	Participants will take part in psychoeducation, videogaming, book club and technology training workshops.
Combined intervention	Cognitive stimulation	Participants will take part in both cognitive stimulation and physical activity intervention sessions.
Combined intervention	Physical activity	Participants will take part in both cognitive stimulation and physical activity intervention sessions.

Primary Outcome Measures

Name	Time	Method
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.
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.

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