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

NCT07276087 | Recruiting

• 1 other identifier: PAU-KAEK-2025-17
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Takayasu Arteritis; Behçet's Disease; Healthy Controls

Keywords

Takayasu arteritis; Behçet's disease; Systemic vasculitis; Muscle strength

Outcome Measures

Primary Outcomes (2)

• Peripheral muscle strength

  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.

  Single assessment (baseline only)

• Respiratory Muscle Strength

  Measured by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable electronic manometer (Micro Medical MicroMPM, UK).

  Single assessment (baseline only)

Secondary Outcomes (9)

• Functional Exercise Capacity-Six-Minute Walk Test (6MWT)

  Single session at baseline

• Functional Status- Health Assessment Questionnaire

  Single session at baseline

• General Health Perception - Visual Analogue Scale (VAS)

  Single assessment at baseline.

• Quality of Life - Short Form-36 Health Survey (SF-36)

  Single session at baseline

• Quality of Life - EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

  Single session at baseline.

Study Arms (3)

Takayasu Arteritis Group

Participants diagnosed with Takayasu arteritis according to established clinical and imaging criteria.

Other: No intervention (observational study)

Behçet's Disease Group

Participants diagnosed with Behçet's disease according to the International Study Group criteria.

Other: No intervention (observational study)

Healthy Control Group

Age- and sex-matched healthy volunteers with no systemic or chronic disease.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

Participants will not receive any treatment or intervention. The study involves only physical and psychosocial assessments and questionnaires.

Behçet's Disease Group; Healthy Control Group; Takayasu Arteritis Group

Eligibility Criteria

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

Study Population

The study population will consist of individuals aged 18 years and older who have been diagnosed with Takayasu arteritis or Behçet's disease and are being followed at the Rheumatology Department of Pamukkale University, as well as age- and sex-matched healthy volunteers without systemic, neurological, or musculoskeletal disease. All participants will provide written informed consent prior to inclusion in the study.

You may qualify if:

• 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.
• 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.
• Age 18 years or older.
• No history of systemic, rheumatologic, or chronic inflammatory disease.
• Voluntary participation with written informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ÖZLEM NUR TOK YAMAN: lead
• Pamukkale University: collaborator
• Uşak University: collaborator
• Alanya Alaaddin Keykubat University: collaborator

Study Sites (1)

Pamukkale University

Denizli, Denizli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis; Behcet Syndrome; Systemic Vasculitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Özlem Nur Tok Yaman, MSc

CONTACT

+90-242-5106060; ozlem.tok@alanya.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer , Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start: September 11, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-10

Locations

TU (1)