| CTRI Number |
CTRI/2025/09/095065 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Progressive muscle loss in knee OA patients |
|
Scientific Title of Study
|
Association of sarcopenia with pain, balance and quality of life in patients with knee osteoarthritis: A Cross-sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Shree Lalitha |
| Designation |
Undergraduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
2nd floor, Sri Ramachandra Faculty of Physiotherapy, SRIHER, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
07200249505 |
| Fax |
|
| Email |
shree7stars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chrysolyte Mohanan |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
2nd floor, Sri Ramachandra Faculty of Physiotherapy, SRIHER
Chennai
TAMIL NADU
600116
India |
| Phone |
9444934432 |
| Fax |
|
| Email |
chrysolyte@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chrysolyte Mohanan |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
2nd floor, Sri Ramachandra Faculty of Physiotherapy, SRIHER
Chennai
TAMIL NADU
600116
India |
| Phone |
9444934432 |
| Fax |
|
| Email |
chrysolyte@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
No. 1 Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rithvik Ramkumar |
Sri Ramachandra Outpatient physiotherapy Block |
Sri Ramachandra Institute of Higher Education and Research No. 1 Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu, India
Chennai
TAMIL NADU |
6380236572
rithvikramkumar3@gmail.com |
| S Shree Lalitha |
Sri Ramachandra Outpatient physiotherapy Block |
Sri Ramachandra Institute of Higher Education and Research
No. 1 Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu, India
Chennai
TAMIL NADU |
07200249505
shree7stars@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults clinically diagnosed with knee osteoarthritis
2.Adults confirmed to have sarcopenia using the Appendicular Skeletal Muscle Index (Body composition analyser).
|
|
| ExclusionCriteria |
| Details |
1.History of recent knee surgery
2.Rheumatoid arthritis,
3.Neurological Disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
|
Base line at the time of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Balance
Quality of life
|
Baseline at the time of enrollment |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
30/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 cross-sectional study will be conducted in the physiotherapy outpatient department with a sample size of 62 patients. This study mainly focuses on assessing whether the participants who have been clinically diagnosed with knee osteoarthritis and confirmed to have sarcopenia have affected Balance, quality of life, and increased pain levels. Participants will include adults aged 60 years and above who have been clinically diagnosed with knee osteoarthritis and confirmed to have sarcopenia using the Appendicular Skeletal Muscle Index (Body composition analyser). Individuals will be excluded if they have a history of knee surgery, rheumatoid arthritis, or present neurological problems. The outcome measures used in this study will include the Numeric Pain Rating Scale (NPRS) to assess pain intensity, the Timed Up and Go (TUG) test to evaluate balance, and the Sarcopenia Quality of Life (SarQoL) questionnaire to assess health-related quality of life in individuals with sarcopenia. |