ClinicalTrials.gov record NCT07276087

Physical and Psychosocial Parameters in Takayasu Arteritis and Behçet's Disease: A Comparative Study With Healthy Controls

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Physical and Psychosocial Parameters in Takayasu Arteritis and Behçet's Disease: A Comparative Study With Healthy Controls

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationTurkey
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an observational, case-control, cross-sectional study comparing people with Takayasu arteritis, people with Behçet's disease, and healthy volunteers. Participants complete a single set of physical tests (muscle and respiratory strength, walk and squat tests) and standard questionnaires about quality of life and illness perception. The study looks for differences between the groups to better describe physical performance and psychosocial health in these diseases.

What it is studying. The study tests whether and how people with Takayasu arteritis or Behçet's disease differ from healthy controls on physical performance (respiratory and peripheral muscle strength, exercise capacity, body composition) and psychosocial measures (quality of life, illness perception, psychological well-being).

What the researchers hope to learn. To identify differences in physical and psychosocial measures between Takayasu arteritis, Behçet's disease, and healthy controls; to provide a multidimensional understanding of how these conditions affect function and well-being; and to inform future physiotherapy, rehabilitation, and multidisciplinary management strategies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • No intervention (observational study)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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, vertigo, epilepsy, etc.).
  • History of any surgical operation within the past year.
  • History of rheumatologic or chronic inflammatory disease.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Systemic vasculitis represents a heterogeneous group of rare inflammatory diseases that affect blood vessel walls, potentially leading to ischemia, tissue damage, and multi-organ dysfunction. Among them, Takayasu arteritis (TAK) and Behçet's disease (BD) are chronic, relapsing vasculitides characterized by systemic inflammation and variable vessel involvement. These diseases may cause not only organ-specific pathology but also generalized effects on muscle strength, physical function, and psychosocial well-being. Previous studies have reported reduced physical performance, fatigue, and impaired quality of life in patients with systemic vasculitis. However, there is limited evidence directly comparing physical and psychosocial parameters between individuals with Takayasu arteritis, Behçet's disease, and healthy controls. The current literature lacks a comprehensive approach addressing the multidimensional impact of these diseases on functional and psychological outcomes. This observational, cross-sectional study aims to fill this gap by evaluating and comparing respiratory and peripheral muscle strength, functional capacity, quality of life, illness perception, and related psychosocial parameters among these three groups. Measurements will include maximal inspiratory and expiratory pressures, handgrip and limb muscle strength via digital dynamometry, functional tests such as the squat test and the six-minute walk test, and standardized self-reported questionnaires including the 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 is expected to provide a multidimensional understanding of how systemic inflammation in Takayasu arteritis and Behçet's disease affects physical and psychosocial functioning. The findings are anticipated to contribute to the literature by highlighting differences between disease groups and healthy controls and to guide future physiotherapy and rehabilitation strategies aimed at improving overall health and quality of life in individuals with systemic vasculitis.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will not receive any treatment as part of the study. In a single baseline session they will have noninvasive physical tests (respiratory muscle strength by maximal inspiratory/expiratory pressures, handgrip and limb strength by dynamometry, squat test, six-minute walk test), body composition measured by bioelectrical impedance, and will complete questionnaires about function, quality of life, illness perception, and general health (HAQ, SF-36, EQ-5D-5L, VAS, IPQ). No invasive procedures are listed; the study involves only assessments and questionnaires.

How the study is structured. Observational case-control, cross-sectional design. Each participant attends a single assessment session with no treatment given. Assessments include breathing muscle tests (maximal inspiratory/expiratory pressures), handgrip and limb strength measurements, functional tests (six-minute walk test, squat test), body composition by bioelectrical impedance, and validated questionnaires (HAQ, SF-36, EQ-5D-5L, VAS, IPQ).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Takayasu Arteritis; Behçet's Disease; Healthy Controls. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Turkey. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

This trial is also listed on this site under Behçet's disease.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 11, 2025
Primary completion
Dec 30, 2025 (estimated)
Study completion
Jan 30, 2026 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Dec 10, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
ÖZLEM NUR TOK YAMAN
Collaborators
  • Pamukkale University
  • Uşak University
  • Alanya Alaaddin Keykubat University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

six-minute walk test
A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Study Group
One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
Control Group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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