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临床试验/CTRI/2024/12/077681
CTRI/2024/12/077681尚未招募不适用

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

Sri Ramachandra Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年12月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
试验地点
1
主要终点
Pain Severity: Visual Analog Scale (VAS)

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Pain Severity: Visual Analog Scale (VAS)

时间窗: At baseline

次要结局

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

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Mr YESHWANTHSS

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

研究点 (1)

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