| CTRI Number |
CTRI/2025/09/095253 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can A Pre-Surgery Health Program Improve Recovery in Patients After Bone And Joint Implant Surgery? |
|
Scientific Title of Study
|
Effects Of A Multimodal Prehabilitation Program On Orthopedic Implant Surgery Outcomes: A 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 |
Auroprakash Pal |
| Designation |
Junior Resident |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Orthopaedics,
Shri Sathya Sai Medical College and Research Institute,
Ammapettai, Chengalpet Taluk, Kancheepuram District, Nellikuppam, Tamil Nadu 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9344628827 |
| Fax |
|
| Email |
auroprakashpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. T Sundararajan |
| Designation |
Professor and Head of Department |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Orthopaedics,
Shri Sathya Sai Medical College and Research Institute,
Ammapettai, Chengalpet Taluk, Kancheepuram District, Nellikuppam, Tamil Nadu 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9344628827 |
| Fax |
|
| Email |
vrtorthocare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Auroprakash Pal |
| Designation |
Junior Resident |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Orthopaedics,
Shri Sathya Sai Medical College and Research Institute,
Ammapettai, Chengalpet Taluk, Kancheepuram District, Nellikuppam, Tamil Nadu 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9344628827 |
| Fax |
|
| Email |
auroprakashpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute, Ammapettai, Chengalpet Taluk, Kancheepuram District, Nellikuppam, Tamil Nadu 603108, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 Auroprakash Pal |
Shri Sathya Sai Medical College And Research Institute |
Shri Sathya Sai Medical College And Research Institute, Ammapettai, Chengalpet Taluk, Kancheepuram District, Nellikuppam, Tamil Nadu 603108
Kancheepuram
TAMIL NADU |
9344628827
auroprakashpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Psychological Counselling
Slow Breathing Exercises
|
Comprehensive Psychological Counselling for 15 min
Slow Breathing Exercises that are known to reduce anxiety and improve vagal tone for 20 min
Total Duration of Intervention: 35 min |
| Comparator Agent |
Standard Preoperative Care |
Standard Preoperative Care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for orthopedic implant
surgery at SSSMCRI |
|
| ExclusionCriteria |
| Details |
Patients who are unwilling to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of a multimodal prehabilitation program (psychological support, breathing exercises, and HRV monitoring) versus standard care on postoperative complications and functional recovery in orthopedic implant surgery patients |
At Baseline, 1 Week And 2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the link of perceived stress score, Hamilton anxiety scale (HAM A)
rating, Flanagan quality of life (QoL) score, immunological parameter, visual
analogue pain scale with implant success, after one week of prehabilitation
program |
At Baseline, 1 Week, 2 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)
|
15/10/2025 |
| 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 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
|
This randomized controlled trial will evaluate a multimodal prehabilitation program combining psychological counselling, slow breathing exercises, and heart rate variability (HRV) monitoring in patients undergoing orthopedic implant surgery. One hundred participants will be randomized into two groups: study (comprehensive prehabilitation plus standard care) and control (standard care alone). The intervention is delivered for one week prior to surgery. Primary outcomes are postoperative complication rate and functional recovery. Secondary measures include stress (PSS-10), anxiety (HAM-A), quality of life (Flanagan QoL), pain scores, HRV indices, body composition, and biochemical markers (IL-6, IgG, MDA). Assessments are taken at admission, after the intervention, and one week post-surgery, with one-year telephonic follow-up for recovery and complications. This study seeks to create a low-cost, structured prehabilitation protocol to optimize perioperative readiness and outcomes in orthopedic implant surgery patients. |