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

NCT07435272 | Not Yet Recruiting

• 1 other identifier: Kinesiophobia in RA
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

Kinesiophobia; Fear of Movement; Rheumatoid Arthritis; Functional Disability; Disease Activity; Pain; Fatigue; Anxiety; Depression; sarcopenia

Outcome Measures

Primary Outcomes (1)

• examine the relationship between kinesiophobia and rheumatoid arthritis

  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

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. All patients included in this study will be verbally briefed about the details and the nature of the study \& will sign a written informed consent according to the local Ethics Committee of Minia University Faculty of Medicine. The study will be conducted in Rheumatology department, Minia university Hospital, Egypt.

You may qualify if:

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

You may not qualify if:

• Juvenile cases
• Other rheumatic diseases (SLE, AS, 1ry OA, etc.)
• Trauma
• 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

Sponsors & Collaborators

• Minia University: lead

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MeSH Terms

Conditions

Kinesiophobia; Arthritis, Rheumatoid; Pain; Fatigue; Anxiety Disorders; Depression; Sarcopenia

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Ahmed Elsayed Hafez, Assistant Professor

  Rheumatology, Rehabilitation and Physical Medicine Department, Faculty of Medicine, Minia University

  PRINCIPAL INVESTIGATOR

• Rasha Samir Refaat, Assistant Professor

  Psychiatry Department, Faculty of Medicine, Minia University

  STUDY CHAIR

• Walaa Fawzy Mohamed, Lecturer

  Rheumatology, Rehabilitation and Physical Medicine department, Faculty of Medicine, Minia University

  STUDY CHAIR

Central Study Contacts

Marwa Abdelhakim Shaban Maghlouf, Resident Doctor

CONTACT

+201154704022; marwat.shaeban422@med.s-mu.edu.eg

Ahmed Elsayed Hafez, Assistant Professor

CONTACT

+201101013625

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02