| 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
|
|
|
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
|
|
|
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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