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临床试验/NCT07435272
NCT07435272尚未招募不适用

Kinesiophobia in Rheumatoid Arthritis: Associations With Functional Disability, Disease Activity, and Related Clinical Factors

Minia University0 个研究点目标入组 400 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
examine the relationship between kinesiophobia and rheumatoid arthritis

研究概览

简要总结

Objectives: Impairment of physical function is a core feature of RA, particularly in patients with high disease activity where pain and inflammation directly limit movement. but, Reduced mobility in RA is not exclusively driven by inflammatory pathology. There are non-inflammatory factors, including kinesiophobia, fatigue, depression, and anxiety, may significantly contribute to functional limitation and may initiate a self-perpetuating cycle in which movement avoidance leads to physical deconditioning, muscle weakness, and progressive functional decline. The aim of this study is to examine the relationship between kinesiophobia and functional outcomes in patients with rheumatoid arthritis, and to investigate its associations with disease activity, pain, fatigue, depressive symptoms, anxiety, and sarcopenia, with a focus on factors relevant to functional assessment and rehabilitation.

Patients and Methods

A case - control study will be conducted on Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA and 200 apparently healthy volunteers with age and sex matching will be involved in the study. The study will be conducted in Rheumatology department, Minia university Hospital, Egypt. All patients will be subjected to history taking, clinical examination, and assessment of the following parameters:

  1. Kinesiophobia: using the Arabic version of TSK-17
  2. Disease activity: using DAS 28
  3. pain severity using the Visual Analogue Scale (VAS)
  4. Fatigue: using the Arabic version of the Fatigue Severity Scale (FSS)
  5. Depression: using the Arabic version of the BDI-2
  6. Anxiety: using the Arabic version of the BAI
  7. sarcopenia using the Arabic version of the SARC-F questionnaire
  8. Functional disability: using the Arabic version of the HAQ-DI
  9. Physical activity:using IPAQ-SF

详细描述

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease affecting approximately 0.5-1% of the global population. It is characterized by persistent synovial inflammation leading to progressive cartilage and bone destruction, resulting in functional impairment and substantial physical, social, and psychological burden.

Impairment of physical function and mobility is a core feature of RA, particularly in patients with high disease activity or advanced joint damage, where pain and inflammation directly limit movement and daily activities.

However, reduced mobility in RA is not exclusively driven by inflammatory pathology. Increasing evidence suggests that non-inflammatory factors, including kinesiophobia, fatigue, depression, and anxiety, may significantly contribute to functional limitation.

Kinesiophobia, defined as an excessive and irrational fear of movement related to pain or perceived risk of injury, constitutes a major challenge for patients with RA. This condition may initiate a self-perpetuating cycle in which movement avoidance leads to physical deconditioning, muscle weakness, and progressive functional decline. Such fear often arises from maladaptive interpretations of pain as a harmful sensory experience, resulting in avoidance behaviors and dysfunctional pain-related cognitions.

In RA, altered pain-related cognitive processing and heightened fear responses appear particularly relevant, contributing to increased kinesiophobia as disease severity progresses. Importantly, elevated disease activity does not necessarily indicate the presence of kinesiophobia, as some patients may experience pain-related functional impairment in the absence of fear of movement. Conversely, kinesiophobia may develop in patients with low disease activity or minimal joint destruction, in whom fear itself-rather than active inflammation-becomes the principal driver of movement avoidance and disability.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: adult population with RA (18-69)
  • Disease duration ≥ 6 months

排除标准

  • Juvenile cases
  • Other rheumatic diseases (SLE, AS, 1ry OA, etc.)
  • Comorbidities that affect mobility, e.g., UMNL (including stroke), parkinsonism, multiple sclerosis, cerebral palsy, dementia, peripheral neuropathy, chronic pain conditions, etc.
  • Previous history of psychiatric illness before onset of RA (anxiety, depression, etc.)
  • Pregnancy and lactation

研究组 & 干预措施

Grpoup 1

Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA

Group 2

200 apparently healthy volunteers with age and sex matching

结局指标

主要结局

examine the relationship between kinesiophobia and rheumatoid arthritis

时间窗: Baseline

examine the correlation between kinesiophobia and functional outcomes in patients with rheumatoid arthritis, and to investigate correlations of Tampa Scale of Kinesiophobia with 1- disease activity using DAS28 2, pain using VAS 3, fatigue using FSS 4, depressive symptoms using BDI II 5, anxiety using BAI 6, sarcopenia using SARC-F 7, functional disability using HAQ-DI 8. and physical activity using IPAQ-SF AA, with a focus on factors

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Abdelhakim Shaban Maghlouf

Resident doctor

Minia University

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