FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/099066 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 14/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of structured Program on cognitive function in older adults with Memory Complaints 
Scientific Title of Study   Effect of a structured multi-component intervention on neurophysiological function in older adults with subjective cognitive impairment– an open label randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  V S SAI SACHIN 
Designation  JUNIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  Department of Geriatric Medicine, All India Institute of Medical Sciences, Virbhadra road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9884669679  
Fax    
Email  saisachin41@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. Monika Pathania 
Designation  Additional Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  Department of Geriatric Medicine, All India Institute of Medical Sciences, Virbhadra road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  81260 21556  
Fax    
Email  saisachin41@gmail.com  
 
Details of Contact Person
Public Query
 
Name  V S SAI SACHIN 
Designation  JUNIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  Department of Geriatric Medicine, All India Institute of Medical Sciences, Virbhadra road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9884669679  
Fax    
Email  saisachin41@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medicial Sciences, Virbhadra road, Rishikesh, India, 249203 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
V S SAI SACHIN  All India Institute of Medical Sciences Rishikesh   Department of Geriatric Medicine, AIIMS, RISHIKESH
Dehradun
UTTARANCHAL 
9884669679

saisachin41@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R40-R46||Symptoms and signs involving cognition, perception, emotional state and behavior,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive stimulation   3 sessions per week for 12 weeks 20 minutes of structured cognitive activities including Playing Ludo for 10 minutes- A traditional board game involving movement of tokens based on dice rolls. It engages working memory, attention, strategic thinking, and promotes social interaction when played in small groups or pairs Storytelling to family for 10 minutes.  
Intervention  Mindfulness – through guided Meditation: (15 minutes)  3 sessions per week for 12 weeks Patients will be taught basic guided meditation practices suitable for older adults. An easy-to-use meditation mobile application will be installed on their personal smartphones. Personalised guidance session will be conducted to ensure they are adequately trained in using the application. Participants will be provided with an illustrated pamphlet detailing the steps for using the application. 
Intervention  Physical activity   3 sessions per week for 12 weeks 5 minutes of warmup exercises 20 minutes of physical exercise (Yoga sequence) 5 minutes of cool-down and stretching  
Comparator Agent  Standard health education   Eat a nutritious balanced diet Limit processed foods and added sugars Maintain a regular sleep schedule Practice good sleep hygiene To quit smoking o Avoid alcohol consumption  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Individuals aged 60 years or older.
2. Screened positive for Subjective Cognitive Impairment (SCI) using the Subjective Cognitive Decline Questionnaire (SCD-Q).
3. Willing and able to provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of a structured multi-component intervention (SMI-combining physical exercise- Yoga based exercises, cognitive training- Ludo/ storytelling, and mindfulness- meditation) on cognitive function (attention, working memory, processing speed and decision-making) over 12 weeks in older adults with subjective cognitive impairment, using the P300 test  At baseline and at 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the change in sleep & mental health status of older adults with subjective cognitive decline, using The Pittsburgh Sleep Quality Index (PSQI), Geriatric Depression Scale (GDS- 15) & Hamilton Anxiety Rating Scale (HAM-A) from baseline to 12 weeks.  At baseline & end of 12 weeks 
2. To assess the effect of SMI on functional balance among subjects with SCD using Berg Balance Scale (BBS).  At baseline & end of 12 weeks  
3. To evaluate the effect of SMI on quality of life among older adults with subjective cognitive decline using Short Form-12 (SF-12) (quality of life) from baseline.  At baseline & end of 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   25/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/06/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

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.


 
Close