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Recruiting Observational

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

NCT07276087 · tracked via the Priya Life Science Turkey tracker
Sponsor
ÖZLEM NUR TOK YAMAN
Phase
Observational
Started
2025-09-11
Last updated
2025-12-10

Condition(s) studied

Takayasu ArteritisBehçet's DiseaseHealthy Controls

Investigational drug(s) / intervention(s)

No intervention (observational study)

No intervention (observational study): Participants will not receive any treatment or intervention. The study involves only physical and psychosocial assessments and questionnaires.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Peripheral muscle strength — Single assessment (baseline only)
    Peripheral muscle strength will be assessed using the Commander Echo™ Muscle Testing Dynamometer (JTECH Medical, USA) for upper and lower extremities. Measurements will include quadriceps, biceps, and shoulder abductor muscle strength. The average of three trials will be recorded in kilograms.
  • Respiratory Muscle Strength — Single assessment (baseline only)
    Measured by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable electronic manometer (Micro Medical MicroMPM, UK).

Trial sites (1)

FacilityCityRegionStatus
Pamukkale University Denizli Denizli Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07276087 on ClinicalTrials.gov ↗ ← All trials in Turkey