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CTRI Number  CTRI/2025/10/095841 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [yoga ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to see whether yoga or physical exercise helps to improve memory and thinking in older adults undergoing major surgery 
Scientific Title of Study   Enhancing Cognitive functionality in Elderly Population Undergoing Major Surgery under General Anaesthesia: A comparative study of Yoga and Physical Prehabilitation Methods 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Puneet Khanna 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 5008 A, Main Building, Teaching Block, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New DELHI

South West
DELHI
110029
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Puneet Khanna 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 5008 A, Main Building, Teaching Block, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New DELHI

South West
DELHI
110029
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Puneet Khanna 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 5008 A, Main Building, Teaching Block, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New DELHI

South West
DELHI
110029
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  Dr. Puneet Khanna 
Address  Room No. 5008 A, Main Building, Teaching Block, Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi-110029 
Type of Sponsor  Other [] 
 
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 
Dr Puneet Khanna  All India Institute of Medical Sciences, New Delhi  Room No. 5008 A, Main Building, Teaching Block, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New Delhi
South West
DELHI 
9873106516

k.punit@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH, AIIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F05||Delirium due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physical Prehabilitation  60-minute supervised sessions once a week for 6 weeks (aerobic, resistance, and stretching), plus a home-based plan of daily walking (30 minutes) and resistance training 3 times a week, following ACSM guidelines. 
Intervention  Yoga  60-minute sessions once a week for 6 weeks, including various breathing exercises and relaxation (e.g., Anulom-Vilom, Udgith, Nadi Shodhana, Bhramari, Sheetali, and Yog Nidra). 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients Age above 60 years.
2. Undergoing major surgery under General Anaesthesia
3. ASA I and ASA II.
4. Fried Frailty Index more than 1
5. There is no minimum cognitive performance required to participate
6. Can give informed consent.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To compare the effect of yoga-based prehabilitation and traditional physical prehabilitation in reducing the occurrence of POD in patients undergoing general major surgery.
2. To evaluate and compare the impact of yoga-based prehabilitation and physical prehabilitation on the incidence and severity of POCD in patients undergoing general major surgery.
 
1. Before Intervention
2. 24 hours before surgery
3. 24 hours after surgery
4. 8 weeks after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the association between specific biomarkers (BDNF, MDA, CRP, TNF-alpha, dopamine, and noradrenaline) and the incidence of POCD and POD in patients participating in yoga-based prehabilitation versus traditional physical prehabilitation.  1. Before Intervention
2. 24 hours before surgery
3. 24 hours after surgery
4. 8 weeks after surgery 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/11/2025 
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="3"
Months="0"
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  

Surgery is essential for treating various diseases but often leads to cognitive complications such as delirium and Postoperative Cognitive Dysfunction (POCD), particularly in older adults. These complications can negatively impact recovery, quality of life, and healthcare costs. While physical prehabilitation is widely recognized for improving surgical outcomes, the role of cognitive prehabilitation remains underexplored. This study compares the effectiveness of yoga-based prehabilitation and physical prehabilitation in enhancing cognitive function before surgery. It will assess key cognitive measures, including attention, processing speed, and memory, in elderly patients undergoing major surgery under general anesthesia.

A total of 200 patients aged 60ys and above will be recruited and randomized into two groups: Group A (Physical Prehabilitation) and Group B (Yoga). Group A will undergo supervised aerobic and resistance exercises, while Group B will participate in guided yoga sessions focusing on breathing techniques and relaxation. Both groups will follow Enhanced Recovery After Surgery (ERAS) guidelines, and cognitive function will be assessed using Depression, Anxiety, and Stress Scale (DASS-21) to evaluate mental states and the Montreal Cognitive Assessment (MoCA) to assess cognitive functions across six domains: memory, executive functioning, attention, language, visuospatial skills, and orientation. Additionally, blood biomarkers (BDNF, MDA, CRP, TNF-Alpha, Dopamine, and Noradrenaline) will be analyzed at multiple time points to evaluate physiological responses to each intervention.

By comparing these two approaches, this study aims to identify the most effective prehabilitation strategy for preserving cognitive health and improving surgical recovery in elderly patients.


 
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