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

NCT07435272 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-03-03

No results posted yet for this study

Summary

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

Conditions

  • Kinesiophobia (Fear of Movement)
  • Rhematoid Arthritis
  • Rheumatoid Arthritis (RA)
  • Rheumatoid

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Ahmed Elsayed Hafez, Assistant Professor · Rheumatology, Rehabilitation and Physical Medicine Department, Faculty of Medicine, Minia University

  • Rasha Samir Refaat, Assistant Professor · Psychiatry Department, Faculty of Medicine, Minia University

  • Walaa Fawzy Mohamed, Lecturer · Rheumatology, Rehabilitation and Physical Medicine department, Faculty of Medicine, Minia University

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-09-01
Completion
2026-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435272 on ClinicalTrials.gov