Physical and Psychosocial Parameters in Takayasu Arteritis and Behçet's Disease: A Comparative Study With Healthy Controls
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorÖZLEM NUR TOK YAMAN
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
No intervention (observational study)
Other interventionParticipants will not receive any treatment or intervention. The study involves only physical and psychosocial assessments and questionnaires.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Takayasu Arteritis Group1 intervention
Group B: Behçet's Disease Group1 intervention
Group C: Healthy Control Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Single assessment (baseline only)2
Respiratory Muscle Strength
Measured by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable electronic manometer (Micro Medical MicroMPM, UK).
Time frame
Single assessment (baseline only)Secondary outcomes
1
Functional Exercise Capacity-Six-Minute Walk Test (6MWT)
Assessed by the Six-Minute Walk Test (6MWT), following standardized ATS/ERS guidelines. Distance walked will be recorded in meters.
Time frame
Single session at baseline2
Functional Status- Health Assessment Questionnaire
Evaluated using the Health Assessment Questionnaire (HAQ). Scores range from 0 to 3, with higher scores indicating worse disability.
Time frame
Single session at baseline3
General Health Perception - Visual Analogue Scale (VAS)
General health perception will be assessed using the Visual Analogue Scale (VAS). The VAS consists of a 100 mm horizontal line anchored by "very good" at one end and "very poor" at the other. Participants are asked to mark a point on the line that best represents their perceived general health. The score is determined by measuring the distance in millimeters from the "very good" anchor to the participant's mark. Higher scores indicate worse perceived health status.
Time frame
Single assessment at baseline.4
Quality of Life - Short Form-36 Health Survey (SF-36)
The SF-36 (Short Form Health Survey) will assess health-related quality of life. Scores range from 0 to 100; higher scores indicate better health status.
Time frame
Single session at baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
ÖZLEM NUR TOK YAMAN
Lead sponsor
Alanya Alaaddin Keykubat University
Sponsor institution
Pamukkale University
Collaborator
Uşak University
Collaborator
Alanya Alaaddin Keykubat University
Collaborator
Source ClinicalTrials.gov