Not Yet RecruitingNot Applicable

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

400 participantsStarted 2026-03-01

Plain-language 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

Who can participate

Age range

18 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

examine the relationship between kinesiophobia and rheumatoid arthritis

Timeframe: Baseline

Trial details

NCT IDNCT07435272

SponsorMinia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

Contact for this trial

Marwa Abdelhakim Shaban Maghlouf, Resident Doctor

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

View on ClinicalTrials.gov More Kinesiophobia (Fear of Movement) trials