| 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
|
|
|
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
|
|
|
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 |
|
|
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. |