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CTRI Number  CTRI/2024/12/077681 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Body Composition Affects Physical Performance in Patient with Knee Osteoarthritis 
Scientific Title of Study   Influence of body composition on physical performance among knee osteoarthritis individuals: A cross-sectional 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  Mr YESHWANTHSS 
Designation  Under graduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  8072360123  
Fax    
Email  t0121074@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Soundararajan 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university 
Address  Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr K Soundararajan 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university 
Address  Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9551163416  
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,Tamil Nadu, India. 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research 
Address  Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 K Soundararajan  Sri Ramachandra Hospital  New Block Physiotherapy OPD, ground Floor, Room No 1, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research [Deemed to be university], Porur, Chennai-600116, Tamil Nadu, India
Chennai
TAMIL NADU 
9551163416

soundararajan.k@sriramachandra.edu.in 
 
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, Tamil Nadu, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Individuals identified with Knee Osteoarthritis
2 Age ≥45 years including both men and women
 
 
ExclusionCriteria 
Details  1 Healthy people
2 People with walking aids
3 Individuals who have medical impairments that affect their ability to walk
4 Participants who are unable to understand or follow instructions due to cognitive impairments or language barriers
5 Pain Score more than 7 in VAS  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain Severity: Visual Analog Scale (VAS)

 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Six-Minute Walk Test (6MWT)  At baseline 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   18/12/2024 
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

Knee osteoarthritis (KOA) is a highly prevalent chronic musculoskeletal condition that affects the bones, muscles, and joints of the knee joint. KOA is often characterized by pain, stiffness, and other functional limitations, such as reduced mobility and difficulty performing everyday tasks. The effects of KOA on physical performance have been well-documented in scientific literature. However, the specific influence of body composition on KOA remains an area of interest and research. Factors such as muscle mass, fat mass, and overall body weight have been shown to play a role in the development and progression of KOA. For example, individuals with a higher body mass index (BMI) are at an increased risk of developing KOA, likely due to the increased load placed on the joint. Moreover, changes in body composition, particularly muscle mass, may affect the severity of KOA symptoms. Research suggests that individuals with higher muscle mass may experience less pain and greater functional ability than those with lower muscle mass. Additionally, fat mass is associated with increased inflammation, which is a key driver of KOA progression. Therefore, understanding the complex interplay between KOA and body composition is crucial for developing effective treatment and management strategies for patients with KOA.

AIM: 

By identifying modifiable risk factors such as body composition, researchers may be able to develop targeted interventions to improve outcomes for individuals with KOA.

OBJECTIVE:

To examine the relationship between body composition including fat mass and muscle mass and physical performance such as mobility, strength, and functional tasks in individuals with KOA.

To identify whether specific body composition parameters are independently associated with physical function.

NEED OF THE STUDY:

Despite existing studies on KOA, there is still a gap in understanding how body composition directly affects physical performance in individuals with knee osteoarthritis. Previous research has shown inconsistent associations, and further investigation is needed to elucidate the specific role of body composition components.

 PROCEDURE:

Institutional Ethical Committee, SRIHER will be obtained and the Study will be registered in the Clinical Trial Registry of India. The participants will be screened for eligibility criteria. Once the participant fulfills the inclusion criteria, informed consent will be obtained and all the baseline assessments will be done for both knee Osteoarthritis individuals. The individuals who will be assessed will undergo a body composition analyzer to assess body composition. Pain severity will be recorded using the VAS. Physical performance tests (6MWT) will be conducted by trained assessors.


 
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