Ankylosing Spondylitis (AS)NCT06650228
Cardiovascular Disease Risk Factors and Healthy Lifestyle Behaviours in Patients with Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis (AS), run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
A review of the literature did not identify any studies that assessed knowledge of cardiovascular disease risk factors and healthy lifestyle behaviours in patients with ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis (AS)
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2024to Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals aged 18-65 years who are clinically stable and diagnosed with ankylosing spondylitis according to ASAS diagnostic criteria and who are being followed up at the Rheumatology Polyclinic of the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study.
Who may be able to join
- Diagnosis of ankylosing spondylitis according to ASAS diagnostic criteria
- Being aged 18-65
- Stable medication use for at least 3 months
- Voluntary participation in the study
Who cannot join
- Having uncontrolled cardiopulmonary disease
- Being pregnant
- Having undergone recent surgery
- Presence of malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirsehir Ahi Evran University
Kırşehir
Merve Firat, Assistant Professor, +90 850 441 02 44, mervefirat@ahievran.edu.tr
About this study
Official title: Assessment of Knowledge of Cardiovascular Disease Risk Factors and Healthy Lifestyle Behaviours in Patients with Ankylosing Spondylitis
A review of the literature did not identify any studies that assessed knowledge of cardiovascular disease risk factors and healthy lifestyle behaviours in patients with ankylosing spondylitis. The aim of this study is to assess knowledge of cardiovascular disease risk factors, healthy lifestyle behaviours and physical activity levels in patients with ankylosing spondylitis.
- Conditions
- Ankylosing Spondylitis (AS)
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ankylosing spondylitis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of cardiovascular disease risk factors
This will be evaluated using The Cardiovascular Disease Risk Factors Knowledge Level scale. The maximum score that can be obtained from the 28-question scale is 28.Higher scores on the scale indicate better knowledge of cardiovascular disease.
Measured: 10 minutes
Healthy lifestyle behaviors
It will be evaluated with the Healthy Lifestyle Behaviors scale II.The lowest score on the whole scale is 52 and the highest is 208. As the score obtained from the survey increases, it is assumed that the participant's level of healthy lifestyle behaviour is high.
Measured: 15 minutes
Secondary outcomes (3)
Physical activity
Physical activity level will be evaluated using International Physical Activity Questionnaire-Short form
Measured: 5 minutes
Cardiovascular risk
The Framingham Risk Score will be calculated to determine cardiovascular risk. Framingham risk score; if the estimated risk of cardiovascular events is above 10%, the risk is considered high; if it is below 10%, the risk is considered low.
Measured: 5 minutes
Comorbidity
Comorbidity level will be evaluated with the Charlson Comorbidity Index
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start22 Oct 2024
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Kirsehir Ahi Evran Universitesi
- Investigators
- Merve Firat, Principal investigator, Kirsehir Ahi Evran UniversitesiBasak Kavalci Kol, Study chair, Kirsehir Ahi Evran UniversitesiFigen Tuncay, Study chair, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650228
- Sponsor's protocol ID
- 2024-13/114
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Knowledge of Cardiovascular Disease Risk Factors and Healthy Lifestyle Behaviours in Patients with Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT06650228
- Acronym / sponsor ID
- 2024-13/114
- Conditions
- Ankylosing Spondylitis (AS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Oct 2024 (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.
A review of the literature did not identify any studies that assessed knowledge of cardiovascular disease risk factors and healthy lifestyle behaviours in patients with ankylosing spondylitis. The aim of this study is to assess knowledge of cardiovascular disease risk factors, healthy lifestyle behaviours and physical activity levels in patients with ankylosing spondylitis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ankylosing spondylitis | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18-65 years who are clinically stable and diagnosed with ankylosing spondylitis according to ASAS diagnostic criteria and who are being followed up at the Rheumatology Polyclinic of the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study.
Key inclusion criteria (4 listed)
- Diagnosis of ankylosing spondylitis according to ASAS diagnostic criteria
- Being aged 18-65
- Stable medication use for at least 3 months
- Voluntary participation in the study
Key exclusion criteria (4 listed)
- Having uncontrolled cardiopulmonary disease
- Being pregnant
- Having undergone recent surgery
- Presence of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge of cardiovascular disease risk factors
Time frame: 10 minutes
This will be evaluated using The Cardiovascular Disease Risk Factors Knowledge Level scale. The maximum score that can be obtained from the 28-question scale is 28.Higher scores on the scale indicate better knowledge of cardiovascular disease.
Healthy lifestyle behaviors
Time frame: 15 minutes
It will be evaluated with the Healthy Lifestyle Behaviors scale II.The lowest score on the whole scale is 52 and the highest is 208. As the score obtained from the survey increases, it is assumed that the participant's level of healthy lifestyle behaviour is high.
3 secondary outcomes
Physical activity
Time frame: 5 minutes
Cardiovascular risk
Time frame: 5 minutes
Comorbidity
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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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. This study is not recruiting at the moment.
Merve Firat principal investigator
Kirsehir Ahi Evran Universitesi
Basak Kavalci Kol study chair
Kirsehir Ahi Evran Universitesi
Figen Tuncay study chair
Kirsehir Ahi Evran Universitesi
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 Ankylosing Spondylitis (AS), run by Kirsehir Ahi Evran Universitesi 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Firat (+90 850 441 02 44 ext. 2490, mervefirat@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of cardiovascular disease risk factors (time frame: 10 minutes). 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 26 Oct 2024.