| 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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- 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.
- 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. |