Takayasu ArteritisNCT07276087
Physical and Psychosocial Parameters in Takayasu Arteritis and Behçet's Disease: A Comparative Study With Healthy Controls
An observational study of Takayasu Arteritis and Behçet's Disease, run by ÖZLEM NUR TOK YAMAN at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Takayasu Arteritis, Behçet's Disease, Healthy Controls
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- Age 18 years or older.
- No history of systemic, rheumatologic, or chronic inflammatory disease.
- Voluntary participation with written informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli, Denizli
Bilge Başakcı Çalık, Prof. Dr., +90-258-296-2000, bbcalik@pau.edu.tr
About this study
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.
Read the 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
- Being tested
- No intervention (observational study)
- Keywords
- Takayasu arteritis, Behçet's disease, Systemic vasculitis, Muscle strength
- Medical subject headings
- Takayasu Arteritis, Behcet Syndrome, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
Participants will not receive any treatment or intervention. The study involves only physical and psychosocial assessments and questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Takayasu Arteritis Group | Participants diagnosed with Takayasu arteritis according to established clinical and imaging criteria. Receives: Other: No intervention (observational study) | |
| Behçet's Disease Group | Participants diagnosed with Behçet's disease according to the International Study Group criteria. Receives: Other: No intervention (observational study) | |
| Healthy Control Group | Age- and sex-matched healthy volunteers with no systemic or chronic disease. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Single assessment (baseline only)
Secondary outcomes (9)
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.
Measured: Single session at baseline
Functional Status- Health Assessment Questionnaire
Evaluated using the Health Assessment Questionnaire (HAQ). Scores range from 0 to 3, with higher scores indicating worse disability.
Measured: Single session at baseline
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.
Measured: Single assessment at baseline.
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.
Measured: Single session at baseline
Quality of Life - EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored from 1 to 5, where higher scores indicate more severe problems. The instrument also includes a Visual Analogue Scale (VAS), on which participants rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health). Higher VAS scores indicate better perceived health.
Measured: Single session at baseline.
Illness Perception - Illness Perception Questionnaire (IPQ)
Illness perception will be assessed using the Illness Perception Questionnaire (IPQ). Higher scores indicate stronger negative illness perceptions.
Measured: Single session at baseline
Fat Mass (kilograms)
Measured via bioelectrical impedance analysis using the Polosmart PSC12 Prolife device. Recorded in kilograms.
Measured: Single session at baseline
Muscle Mass (kilograms)
Measured via bioelectrical impedance analysis using the Polosmart PSC12 Prolife device. Recorded in kilograms.
Measured: Single session at baseline
Body Fat Percentage
Measured via bioelectrical impedance analysis using the Polosmart PSC12 Prolife device. Recorded as percentage of total body weight.
Measured: Single session at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start11 Sep 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ÖZLEM NUR TOK YAMAN
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University, Uşak University, Alanya Alaaddin Keykubat University
- Responsible party
- Sponsor-investigator, ÖZLEM NUR TOK YAMAN, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276087
- Sponsor's protocol ID
- PAU-KAEK-2025-17
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Psychosocial Parameters in Takayasu Arteritis and Behçet's Disease: A Comparative Study With Healthy Controls
- ClinicalTrials.gov ID
- NCT07276087
- Acronym / sponsor ID
- PAU-KAEK-2025-17
- Conditions
- Takayasu Arteritis, Behçet's Disease, Healthy Controls
- Keywords
- Takayasu arteritis, Behçet's disease, Systemic vasculitis, Muscle strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ÖZLEM NUR TOK YAMANUniversity, hospital or other
- Collaborators
- Pamukkale University, Uşak University, Alanya Alaaddin Keykubat University
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Takayasu Arteritis Group | – | Other: No intervention (observational study)Participants diagnosed with Takayasu arteritis according to established clinical and imaging criteria. |
| Behçet's Disease Group | – | Other: No intervention (observational study)Participants diagnosed with Behçet's disease according to the International Study Group criteria. |
| Healthy Control Group | – | Other: No intervention (observational study)Age- and sex-matched healthy volunteers with no systemic or chronic disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)Participants will not receive any treatment or intervention. The study involves only physical and psychosocial assessments and questionnaires. | Other | Behçet's Disease Group, Healthy Control Group, Takayasu Arteritis Group |
Primary outcome
Peripheral muscle strength
Time frame: 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
Time frame: Single assessment (baseline only)
Measured by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable electronic manometer (Micro Medical MicroMPM, UK).
9 secondary outcomes
Functional Exercise Capacity-Six-Minute Walk Test (6MWT)
Time frame: Single session at baseline
Functional Status- Health Assessment Questionnaire
Time frame: Single session at baseline
General Health Perception - Visual Analogue Scale (VAS)
Time frame: Single assessment at baseline.
Quality of Life - Short Form-36 Health Survey (SF-36)
Time frame: Single session at baseline
Quality of Life - EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time frame: Single session at baseline.
Illness Perception - Illness Perception Questionnaire (IPQ)
Time frame: Single session at baseline
Fat Mass (kilograms)
Time frame: Single session at baseline
Muscle Mass (kilograms)
Time frame: Single session at baseline
Body Fat Percentage
Time frame: Single session at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takayasu Arteritis and Behçet's Disease, run by ÖZLEM NUR TOK YAMAN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özlem Nur Tok Yaman, MSc (+90-242-5106060, ozlem.tok@alanya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral muscle strength (time frame: Single assessment (baseline only)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.