Physical and Psychosocial Parameters in Takayasu Arteritis and Behçet's Disease: A Comparative St… (NCT07276087) | Clinical Trial Compass
RecruitingNot Applicable
Physical and Psychosocial Parameters in Takayasu Arteritis and Behçet's Disease: A Comparative Study With Healthy Controls
Turkey (Türkiye)30 participantsStarted 2025-09-11
Plain-language summary
Systemic vasculitis refers to a group of rare diseases characterized by inflammation of blood vessel walls, which may cause ischemia and structural damage in various organs. Among large-vessel vasculitides, Takayasu arteritis primarily affects the aorta and its main branches, whereas Behçet's disease is a variable vessel vasculitis involving arteries and veins of all sizes. Both conditions can lead to multisystemic involvement and significantly impact physical and psychosocial health.
This observational, case-control study aims to compare multiple physical and psychosocial parameters among individuals with Takayasu arteritis, Behçet's disease, and healthy controls. Assessments will include respiratory and peripheral muscle strength, functional status, exercise capacity, body composition, quality of life, illness perception, and psychological well-being. Measurements will be conducted using standardized clinical tests (such as maximal inspiratory and expiratory pressures, handgrip and limb strength dynamometry, squat test, and six-minute walk test) and validated questionnaires (Health Assessment Questionnaire (HAQ), the Short Form-36 Health Survey (SF-36), the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L), and the Visual Analogue Scale (VAS)).
The study seeks to identify differences between groups and provide a comprehensive understanding of how systemic inflammation in Takayasu arteritis and Behçet's disease affects physical performance, quality of life, and psychosocial health. These findings may help guide physiotherapy, rehabilitation, and multidisciplinary management strategies for patients with systemic vasculitis.
Who can participate
Age range
18 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.
Inclusion Criteria:
Inclusion Criteria (Takayasu Arteritis Group):
* Age 18 years or older.
* Diagnosis of Takayasu arteritis according to the American College of Rheumatology (ACR) classification criteria.
* Voluntary participation with written informed consent.
Inclusion Criteria (Behçet's Disease Group):
* Age 18 years or older.
* Diagnosis of Behçet's disease according to the International Study Group for Behçet's Disease criteria.
* Voluntary participation with written informed consent.
Inclusion Criteria (Healthy Control Group):
* Age 18 years or older.
* No history of systemic, rheumatologic, or chronic inflammatory disease.
* Voluntary participation with written informed consent.
Exclusion Criteria:
Exclusion Criteria (Patient Groups - Takayasu Arteritis and Behçet's Disease):
* Pregnancy.
* Presence of psychiatric disorder or ongoing psychiatric treatment.
* Cognitive impairment that may interfere with participation.
* Presence of neurological disease (e.g., hemiplegia, Parkinson's disease, multiple sclerosis, vertigo, epilepsy, etc.).
* History of any surgical operation within the past year.
* Coexisting rheumatic disease other than Takayasu arteritis or Behçet's disease.
Exclusion Criteria (Healthy Control Group):
* Pregnancy.
* Presence of psychiatric disorder or ongoing psychiatric treatment.
* Cognitive impairment that may interfere with participation.
* Presence of neurological disease (e.g., hemiplegia, Parkinson's disease, multiple sclerosis, verti…
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.
1Since this study is comparing people with Takayasu Arteritis or Behçet's Disease to healthy controls rather than testing a new treatment, what would I actually gain from participating — and would it involve any changes to my current care?
2The study is measuring peripheral muscle strength and respiratory muscle strength — does my doctor think my current level of muscle or breathing function is something worth formally assessing right now, and could the results from this study inform my ongoing treatment?
3Because this is listed as Phase NA, meaning it's an observational or measurement study rather than a drug or intervention trial, are there any physical tests or procedures involved that could pose any risk given the activity limitations that often come with Takayasu Arteritis or Behçet's Disease?
4Given that this is a comparative study and not a treatment trial, would my doctor recommend I consider this alongside, or instead of, pursuing any active treatment options or other clinical trials that might more directly address my symptoms?
5If the study findings reveal something notable about my muscle strength or respiratory function during participation, would that information be shared with me and my care team in a way that could actually influence my treatment plan?
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.