跳至主要内容
临床试验/CTRI/2025/12/099066
CTRI/2025/12/099066尚未招募不适用

Effect of a structured multi-component intervention on neurophysiological function in older adults with subjective cognitive impairment– an open label randomized controlled trial

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1

研究概览

简要总结

With increasing life expectancy, age-related cognitive decline and dementia have become major global public health concerns. Subjective Cognitive Decline (SCD) represents the earliest symptomatic stage in the Alzheimer’s disease (AD) continuum, characterized by self-perceived cognitive worsening despite normal neuropsychological performance. It is highly prevalent among older adults and often associated with anxiety, depression, reduced quality of life and increased risk of progression to Mild Cognitive Impairment (MCI) and dementia. As disease-modifying treatments for AD remain unsuccessful, research is shifting towards early preventive, non-pharmacological, multi-domain interventions.

Lifestyle-based approaches incorporating physical exercise, cognitive training, diet modification, and psychosocial engagement have shown promising but inconsistent outcomes. Literature indicates that multimodal physical activity programs can improve psychological wellbeing and show delayed cognitive gains, while computerised and gamified cognitive training enhances processing speed, executive function and global cognition. Memory strategy training and metacognitive approaches reduce subjective memory complaints by improving compensatory strategy use. Culturally integrated mind–body therapies such as yoga, meditation, and traditional cognitive practices further enhance cognitive function, emotional wellbeing, and engagement. However, research gaps include limited long-term evidence, small sample sizes, lack of culturally tailored models and insufficient studies combining multiple components synergistically.

The P300 event-related potential is a sensitive neurophysiological marker reflecting attentional and memory processing. It can detect early cognitive deterioration before overt impairment and is emerging as an objective tool for tracking progression in SCD.

This randomized controlled trial aims to evaluate the effect of a 12-week Structured Multi-component Intervention (SMI)—combining yoga-based physical exercise, cognitive training through Ludo/storytelling, and mindfulness meditation—on P300 latency in older adults with SCD. One hundred participants will be randomized into intervention and control groups. Primary outcome is change in P300 latency; secondary outcomes include sleep quality, anxiety, depression, balance and quality of life measured using PSQI, GDS-15, HAM-A, BBS and SF-12. The study intends to generate evidence supporting culturally appropriate, scalable multi-domain programs for early cognitive health promotion and dementia prevention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Individuals aged 60 years or older.
  • Screened positive for Subjective Cognitive Impairment (SCI) using the Subjective Cognitive Decline Questionnaire (SCD-Q).
  • Willing and able to provide written informed consent to participate in the study.

排除标准

  • 未提供

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

V S SAI SACHIN

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH

研究点 (1)

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