跳至主要内容
临床试验/CTRI/2025/08/093096
CTRI/2025/08/093096招募中不适用

Multicomponent intervention for improving cognitive function among community dwelling older adults with type 2 diabetes A nonrandomized intervention study

Indian Council of Medical Research ICMR1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
220
试验地点
1
主要终点
The trial will study the effectiveness of a non-drug intervention in improving cognitive and everyday functions in older adults with diabetes. It will assess changes in attention, memory, processing speed, executive function, and global cognition. The intervention’s impact on cognitive capacities will be evaluated before and after its implementation.

研究概览

简要总结

Aging and type-2 diabetes (T2DM) are correlated with increased odds of accelerated cognitive decline. Research shows that diabetes increases cognitive impairment risk, and cognitive impairment makes diabetes self-management more challenging in the elderly. Novelty: Given the lack of affordable, effective drugs to mitigate dementia or cognitive decline in diabetic elderly, the importance of non-drug intervention is emphasized in this research. Objectives: To investigate the effect of a multicomponent intervention program on cognitive function and physical functionality in older adults with T2DM. Methods: A non-randomized controlled trial including older adults with T2DM and mild cognitive impairment will be recruited from multisite diabetes clinics in the Pune city area. The trial will recruit total176 participants who meet the study’s inclusion and exclusion criteria. Participants will be divided into two groups (88 each) for a 12-week intervention that combines exercise and cognitive training, and a control group that receives usual care. The participant will be evaluated systematically using the questionnaire and neuropsychological test at the three time points: baseline, immediate post intervention, 6-month post intervention. Descriptive statistics and appropriate parametric and non-parametric tests will be conducted to see the effect of intervention and differences in the group. Cohen’s d will be calculated to determine the effect size .Expected outcome: The study will fill an important gap by addressing cognitive function in the management of diabetes. Improvements in cognitive performance as a result of intervention can translate into improved performance in everyday life and, possibly, diabetes self-management.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
60.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adults of either gender aged 60 to 70 years With diagnosis of type II diabetes for 5 or more years Education 8th grade and above With MoCA score between 18 to 25 Able to provide written consent.

排除标准

  • Pre existing cognitive conditions such as dementia and Alzheimer Known vascular complications of diabetes such as coronary artery disease stroke nephropathy retinopathy and polyneuropathy and other which may have compromised the physical integrity of the patient.
  • Other chronic diseases or medical condition restricting physical exercise.
  • Unable to understand Marathi English Subjects who have undergone or currently enrolled in a regimen of physical exercise Patients with psychiatric disorders or on medication example sedatives antipsychotics etc that are known to affect memory and psychomotor functions.

结局指标

主要结局

The trial will study the effectiveness of a non-drug intervention in improving cognitive and everyday functions in older adults with diabetes. It will assess changes in attention, memory, processing speed, executive function, and global cognition. The intervention’s impact on cognitive capacities will be evaluated before and after its implementation.

时间窗: Cognitive test using MOCA, Wechsler Adult intelligence scale WAIS will be used to measure attention, processing speed. Trail making will be used to measure executive functioning at baseline before the start of the intervention, at 13th week after the completion of the intervention and at 6 months post intervention.

次要结局

  • Secondary outcomes include changes inHbA1C levels, daily living activities scores and change in depression scores.(HbA1C levels, functionality and depression will be measured at baseline before the intervention, at 13th week immediately after the intervention and at 6 months post intervention)

研究者

发起方
Indian Council of Medical Research ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Aarti Nagarkar

Savitribai Phule Pune University

研究点 (1)

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