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Clinical Trials/CTRI/2024/12/077681
CTRI/2024/12/077681
Not yet recruiting
Not Applicable

Influence of body composition on physical performance among knee osteoarthritis individuals: A cross-sectional observational study

Sri Ramachandra Institute of Higher Education and Research1 site in 1 country106 target enrollmentStarted: December 18, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
106
Locations
1
Primary Endpoint
Pain Severity: Visual Analog Scale (VAS)

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
45.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Individuals identified with Knee Osteoarthritis 2 Age ≥45 years including both men and women.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pain Severity: Visual Analog Scale (VAS)

Time Frame: At baseline

Secondary Outcomes

  • Six-Minute Walk Test (6MWT)(At baseline)

Investigators

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Mr YESHWANTHSS

Sri Ramachandra Institute of Higher Education and Research[Deemed to be university]

Study Sites (1)

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