| CTRI Number |
CTRI/2025/01/079621 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical activity and sarcopenia in knee osteoarthritis |
|
Scientific Title of Study
|
Association between physical activity and sarcopenia among individuals with knee osteoarthritis: An observational 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 |
Moneka C |
| Designation |
Under graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
06379932549 |
| Fax |
|
| Email |
monekac03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
06379932549 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
06379932549 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai - 600116, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy, 1st floor, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur |
| Type of Sponsor |
Private medical college |
|
|
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 S Rahul |
Sri Ramachandra Institute of Higher Education and Research |
Faculty of Physiotherapy, 2nd floor, room no 2.4, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), porur
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
08148003482
skphysio95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students project, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai - 600116, Tamilnadu, India |
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 |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects identified with knee pain and asymptomatics
Age18 years including both men and women |
|
| ExclusionCriteria |
| Details |
Have other significant musculoskeletal or neurological conditions affecting mobility.
Subjects who are unable to participate in physical activity assessments or interventions
Have a history of significant cardiovascular events or conditions that may limit exercise participation.
Are currently undergoing treatment that may affect muscle mass or physical performance.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Composition Analyser |
At the Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The International Physical Activity Questionnaire (IPAQ) |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
10/02/2025 |
| 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
|
BACKGROUND As individuals age, several changes in body composition occur which include the progressive decline in muscle mass and strength, which begins as early as the 30s. An increase in Adiposity (accumulation of fat) tends to increase. These changes have significant implications for health and well-being. Increased adiposity is associated with knee osteoarthritis (KOA), which is a well-known risk factor for various health conditions, including cardiovascular diseases, diabetes, and reduced quality of life. Sarcopenia refers to the loss of skeletal muscle mass, strength, and physical performance. It contributes to frailty, disability, and decreased overall functioning. When sarcopenia and KOA coexist, this combination poses additional health risks and challenges. AIM: The aim of this study is to investigate the association between physical activity levels and the prevalence of sarcopenia in individuals diagnosed with knee osteoarthritis. OBJECTIVE: Primary objective: รข The primary objective of this study is to determine the impact of physical activity levels on the development of sarcopenia in individuals with knee osteoarthritis. Secondary objectives: To assess the differences in physical activity levels and sarcopenia scores among individuals with knee osteoarthritis. To explore the relationship between physical activity levels, sarcopenia, and knee osteoarthritis. METHODOLOGY: Study design: Observational Study Study sampling: Purposive Sampling Study duration: 3 months or 6 months Study setting: Out-Patient Physiotherapy Department, Sri Ramachandra Hospitals Study population: Knee Osteoarthritis Study blinding: Group allocator, Outcome assessor, Statistics analyzer. |