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CTRI Number  CTRI/2026/01/101888 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   a Study to examine the Effect of exercises before knee replacement surgery  
Scientific Title of Study   Effect of structured prehabilitation on the clinical outcomes and functional independence following total knee replacement - A quasi experimental study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  HANNAH CHRYSOLITE S 
Designation  POST GRADUATE 
Affiliation  Sri Ramachandra institute of higher education and research 
Address  2nd floor, Sri Ramachandra Faculty of Physiotherapy, plot NO:1, Ramachandra Nagar, Porur, chennai, Tamilnadu- 600116

Chennai
TAMIL NADU
600116
India 
Phone  8778117988  
Fax    
Email  chrysolitehannah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chrysolyte M 
Designation  Assistant Professor 
Affiliation  SRIHER 
Address  2nd floor, Sri Ramachandra Faculty of Physiotherapy, SRIHER NO:1, Ramachandra Nagar, Porur, chennai, Tamilnadu

Chennai
TAMIL NADU
600116
India 
Phone  9444934432  
Fax    
Email  chrysolyte@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Chrysolyte M 
Designation  Assistant Professor 
Affiliation  SRIHER 
Address  2nd floor, Sri Ramachandra Faculty of Physiotherapy, SRIHER NO:1, Ramachandra Nagar, Porur, chennai, Tamilnadu

Chennai
TAMIL NADU
600116
India 
Phone  9444934432  
Fax    
Email  chrysolyte@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri RAamchandra Institute of Higher Education and Research, Porur, Chennai 600116, Tamil nadu. 
 
Primary Sponsor  
Name  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCAGTION AND RESEARCH 
Address  SRIHER NO1, RAMACHANDRA NAGAR, PORU, CHENNAI, TAMILNADU 600116 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 HANNAH CHRYSOLITE S  Sri Ramachandra Institute of Higher Education and Research  SRIHER NO:1, Ramachandra Nagar, Porur, chennai, Tamilnadu- 600116
Chennai
TAMIL NADU 
08778117988

chrysolitehannah@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: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Prehabilitation exercises  Prehabilitation assessment Post operative rehabilitation over view, Education of the patients condition and procedure - 6 weeks 
Comparator Agent  Standard Care   Verbal exercises and exercise pamplet 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Adults aged 45–75 years
2.Scheduled for elective unilateral TKR
3.Able to understand and consent
 
 
ExclusionCriteria 
Details  1.Revision TKR
2. Cognitive impairments
3. Prior exposure to similar educational content
4. Patients undergoing bilateral TKR in the same admission.
5. Those with severe visual or hearing impairment that prevents following video content.
6. Patients with neurological or musculoskeletal disorders (e.g., Parkinson’s disease, stroke, severe hip arthritis) that may affect gait and functional assessment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Timed up and go test   Baseline before surgery, 6 weeks after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Knee range of motion, muscle power, self administered questionnairre  baseline, 6 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   05/02/2026 
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="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 31-01-2026 and end date provided 31-01-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

STAGE 1:

Preparing and validating the prehabilitation video: After performing extensive literature search the exercises which are to be included were formulated as video starting from osteoarthritis and surgical procedure to post operative rehabilitation strategies are explained in the video with a brief pre-operative exercise program. Validation would be done by sending the video to few experts in the field of joint replacement including orthopedicians and physiotherapists and collecting the content and video clarity through a questionnaire and appropriate statistics are used.

STAGE 2:

Patient who are planned for TKR will be screened based on the inclusion and exclusion criteria and included in the study after obtaining written inform consent. Demographic data and baseline parameters knee flexion ROM, knee extension strength, TUG test, along with a self-administered questionnaire assessing their expectation, confidence and familiarity with exercises are collected.      Following this, participants viewed a content validated, 15 minute educational video that provided an overview of the surgical procedure, expected recovery timeline, pain management strategies, rehabilitation goals, addressing realistic outcomes. After the video, patients reassessed their expectations through a post-session questionnaire and the prehab exercises would be reviewed. Patients would be given routing physiotherapy care, after 6 weeks all the outcomes were reassessed. Data collected from the self administred questionnairre, along with postoperative outcomes, were analyzed using paired t-tests to determine the effectiveness of the intervention. The control group receives standard preoperative care, including verbal guidance on exercises.

 
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