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临床试验/NCT06376656
NCT06376656进行中(未招募)不适用

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

Sunway University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
2
主要终点
Cost-benefit analysis of intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Non-intervention control

No Intervention

Participants will not take part in any intervention.

Cognitive stimulation

Experimental

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

干预措施: Cognitive stimulation (Behavioral)

Physical activity

Experimental

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

干预措施: Physical activity (Behavioral)

Combined intervention

Experimental

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

干预措施: Cognitive stimulation (Behavioral)

Combined intervention

Experimental

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

干预措施: Physical activity (Behavioral)

结局指标

主要结局

Cost-benefit analysis of intervention

时间窗: 4 years

The economic benefits from the interventions will be evaluated and will cover three aspects: financial, productivity and health.

Changes in cognitive scores

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 4 years

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

Changes in salivary telomere length

时间窗: 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

时间窗: 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.

次要结局

  • Changes in anxiety scores(4 years)
  • Changes in depression scores(4 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YookChin Chia

Professor, Head of Department of Medical Sciences, School of Medical and Life Sciences and Programme Leader of Postgraduate Diploma In Primary Care For Elderly

Sunway University

研究点 (2)

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