| 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 |
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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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|
|
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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.
|
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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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 |
|
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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.
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