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

NCT ID: NCT07276087

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-11
• Study Completion Date: 2026-01-30

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.

Detailed Description

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.

Conditions

Takayasu Arteritis; Behçet's Disease; Healthy Controls

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Takayasu Arteritis Group

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

No intervention (observational study)

Intervention Type: OTHER

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

Behçet's Disease Group

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

No intervention (observational study)

Intervention Type: OTHER

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

Healthy Control Group

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

No intervention (observational study)

Intervention Type: OTHER

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

Interventions

No intervention (observational study)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pamukkale University

OTHER

Sponsor Role: collaborator

Uşak University

OTHER

Sponsor Role: collaborator

Alanya Alaaddin Keykubat University

OTHER

Sponsor Role: collaborator

ÖZLEM NUR TOK YAMAN

OTHER

Sponsor Role: lead

Responsible Party

ÖZLEM NUR TOK YAMAN

Lecturer , Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Pamukkale University

Denizli, Denizli, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Özlem Nur Tok Yaman, MSc

Role: CONTACT

ozlem.tok@alanya.edu.tr

+90-242-5106060

Facility Contacts

Bilge Başakcı Çalık, Prof. Dr.

Role: primary

bbcalik@pau.edu.tr

+90-258-296-2000

Other Identifiers

PAU-KAEK-2025-17

Identifier Type: -

Identifier Source: org_study_id