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CTRI Number  CTRI/2025/08/093096 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Cognitive training]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Physical and cognitive training program to improve memory and thinking abilities in older adults with type 2 diabetes 
Scientific Title of Study   Multicomponent intervention for improving cognitive function among community dwelling older adults with type 2 diabetes A nonrandomized intervention study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarti Nagarkar 
Designation  Associate Professor 
Affiliation  Savitribai Phule Pune University 
Address  Office no 10 Department of Health Sciences Savitribai Phule Pune University

Pune
MAHARASHTRA
411007
India 
Phone  9822437743  
Fax    
Email  amnagarkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aarti Nagarkar 
Designation  Associate Professor 
Affiliation  Savitribai Phule Pune University 
Address  Office no 10 Department of Health Sciences Savitribai Phule Pune University

Pune
MAHARASHTRA
411007
India 
Phone  9822437743  
Fax    
Email  amnagarkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aarti Nagarkar 
Designation  Associate Professor 
Affiliation  Savitribai Phule Pune University 
Address  Office no 10 Department of Health Sciences Savitribai Phule Pune University

Pune
MAHARASHTRA
411007
India 
Phone  9822437743  
Fax    
Email  amnagarkar@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research ICMR 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  V Ramalingaswami Bhawan PO Box No 4911Ansari Nagar New Delhi 110029 India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aarti Nagarkar  Department of Health Sciences  Office no 10, Department of Health Sciences Savitribai Phule Pune University Ganeshkhind Pune
Pune
MAHARASHTRA 		 9822437743

amnagarkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee Savitribai Phule Pune University Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Diabetes mild cognitive impairment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Multicomponent intervention for improving cognitive function among diabetic older adults  Participants in the control group will not be given any material of the intervention directly. But they will be advised on nutrition and diet, frailty and falls in these 12 weeks. This is maintain connection with the participants.  
Intervention  Multicomponent intervention for improving cognitive function among diabetic older adults  This is 12 week multicomponent intervention with 24 sessions 2 per week. The intervention consists of various cognitive training activities across the 24 sessions gradually increasing the level of difficulty from low low intermediate medium medium intermediate and high. The activities developed target 4 cognitive domains low low intermediate medium medium intermediate and high. The multicomponent intervention will also consists of physical activity focusing on balance, co-ordination, strengthening and dual tasks in the seated and standing positions levels of complexity critical points and variations. The third component of education and counselling will contain: Patient education on diet and nutrition, importance of sleep Medication adherence and other tips for well-being  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.   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.  
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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