Axial SpondyloarthritisNCT05019547
The Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
An observational study of Axial Spondyloarthritis, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Our aim in this study is to translate the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors that facilitate and prevent individuals for physical activity for patients with inflammatory arthritis into Turkish language. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Determining Barriers and Facilitators of Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 10 Dec 2021
- 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: Axial Spondyloarthritis
Who may be able to join
- Being 18 years or older,
- Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist
- To have the neurological competence and cognitive level to answer the scale questions.
Who cannot join
- Having a rheumatological disease other than Axial Spondyloarthritis ,
- Using an assistive device for walking.
- Any verbal or written communication problems in Turkish,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Research and Training Hospital
Istanbul
About this study
Official title: Validity and Reliability of the Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
Our aim in this study is to translate the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors that facilitate and prevent individuals for physical activity for patients with inflammatory arthritis into Turkish language. Also, our aim is to evaluate the validity and reliability of the IFAB Questionnaire in the Turkish population, and to perform a cultural adaptation if necessary at the same time. Determining the factors that facilitate and prevent individuals for physical activity interventions with rheumatic diseases and then designing physical activity programs considering these factors may play an important role in reducing the symptoms caused by the disease and increasing their quality of life.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Determining Barriers and Facilitators of Physical Activity
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining Barriers and Facilitators of Physical ActivityBehavioural
Determining Barriers and Facilitators of Physical Activity
| Study group | Role | What they receive |
|---|---|---|
| Axial Spondyloarthritis | Participants with Axial Spondyloarthritis Receives: Behavioral: Determining Barriers and Facilitators of Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Arthritis Barriers and Facilitators to Physical Activity Questionnaire (IFAB)
The IFAB Questionnaire was developed by Davergne et al. in 2020 and aims to evaluate the factors that facilitate or prevent physical activity in individuals with inflammatory arthritis. The IFAB questionnaire consists of 10 items. Of these 10 items, 4 were identified as potential barriers or facilitators, 3 as only barriers and 3 as only facilitators. The participant is asked to rate how much the item facilitates or prevents from physical activity between 0 and 10, "0" has no effect on physical activity, and "10" has maximum (negative or positive) effect on physical activity. A high score from the questionnaire indicates that the facilitators are at a high level and the barriers are at a low level.
Measured: 1 day
The Exercise Benefits or Barriers Scale
The Exercise Benefits and Barriers Scale has been developed by Sechrist et al. and the Turkish validity and reliability studies were conducted by Ortabağ et al. This scale will be used to evaluate criterion validity which evaluates the benefits and barriers of exercise perceived by the individual on a 4-point Likert-type scale with 43 questions. Scoring is performed as barrier score, benefit score and total score. A low score means less perceived barriers to exercise and greater benefits.
Measured: 1 day
International Physical Activity Questionnaire - Short Form
The physical activity level reported by the participants will be evaluated with the International Physical Activity Questionnaire - Short Form. The International Physical Activity Questionnaire - Short Form questions the time spent walking, moderate and vigorous activities, and sitting with 7 questions. The duration (minutes) and frequency (days) of each activity are questioned. The physical activity levels of the participants will be classified as inactive, minimally active and very active according to the results.
Measured: 1 day
Secondary outcomes (2)
Hospital Anxiety and Depression Scale (HADS)
The HADS scale was developed to assess anxiety and depression in individuals without psychiatric illness. Of the 14-item questionnaire, 7 questions assess depression and 7 questions assess anxiety and each response consists of a four-point rating scale (0 to 3); a higher score indicates a worse condition.For each subscale the total score is at most 21.
Measured: 1 day
Health Assessment Questionnaire - Disability Index
This questionnaire evaluates the level of functional disability in patients with rheumatological disease over 20 questions. It determines the level of difficulty of the person during the activities that are most frequently performed in daily life such as dressing, eating, hygiene, walking, sitting up, reaching and grasping. A high score indicates a low level of functionality.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Sep 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019547
- Sponsor's protocol ID
- ATADEK 2021 - 15
- Status last verified
- Dec 2021
- First submitted
- 19 Aug 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozturk O, Feyzioglu O, Saritas F. Inflammatory Arthritis Facilitators and Barriers (IFAB) for physical activity questionnaire: cross-cultural adaptation into Turkish and evaluation of its psychometric properties. Disabil Rehabil. 2023 Aug;45(17):2818-2825. doi: 10.1080/09638288.2022.2104940. Epub 2022 Aug 1.
PubMed 35914576
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
- ClinicalTrials.gov ID
- NCT05019547
- Acronym / sponsor ID
- ATADEK 2021 - 15
- Conditions
- Axial Spondyloarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 25 Aug 2021 (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.
Our aim in this study is to translate the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors that facilitate and prevent individuals for physical activity for patients with inflammatory arthritis into Turkish language. Also, our aim is to evaluate the validity and reliability of the IFAB Questionnaire in the Turkish population, and to perform a cultural adaptation if necessary at the same time. Determining the factors that facilitate and prevent individuals for physical activity interventions with rheumatic diseases and then designing physical activity programs considering these factors may play an important role in reducing the symptoms caused by the disease and increasing their quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axial Spondyloarthritis | – | Behavioral: Determining Barriers and Facilitators of Physical ActivityParticipants with Axial Spondyloarthritis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Axial Spondyloarthritis
Key inclusion criteria (3 listed)
- Being 18 years or older,
- Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist
- To have the neurological competence and cognitive level to answer the scale questions.
Key exclusion criteria (3 listed)
- Having a rheumatological disease other than Axial Spondyloarthritis ,
- Using an assistive device for walking.
- Any verbal or written communication problems in Turkish,
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 |
|---|---|---|
| Determining Barriers and Facilitators of Physical ActivityDetermining Barriers and Facilitators of Physical Activity | Behavioural | Axial Spondyloarthritis |
Primary outcome
Inflammatory Arthritis Barriers and Facilitators to Physical Activity Questionnaire (IFAB)
Time frame: 1 day
The IFAB Questionnaire was developed by Davergne et al. in 2020 and aims to evaluate the factors that facilitate or prevent physical activity in individuals with inflammatory arthritis. The IFAB questionnaire consists of 10 items. Of these 10 items, 4 were identified as potential barriers or facilitators, 3 as only barriers and 3 as only facilitators. The participant is asked to rate how much the item facilitates or prevents from physical activity between 0 and 10, "0" has no effect on physical activity, and "10" has maximum (negative or positive) effect on physical activity. A high score from the questionnaire indicates that the facilitators are at a high level and the barriers are at a low level.
The Exercise Benefits or Barriers Scale
Time frame: 1 day
The Exercise Benefits and Barriers Scale has been developed by Sechrist et al. and the Turkish validity and reliability studies were conducted by Ortabağ et al. This scale will be used to evaluate criterion validity which evaluates the benefits and barriers of exercise perceived by the individual on a 4-point Likert-type scale with 43 questions. Scoring is performed as barrier score, benefit score and total score. A low score means less perceived barriers to exercise and greater benefits.
International Physical Activity Questionnaire - Short Form
Time frame: 1 day
The physical activity level reported by the participants will be evaluated with the International Physical Activity Questionnaire - Short Form. The International Physical Activity Questionnaire - Short Form questions the time spent walking, moderate and vigorous activities, and sitting with 7 questions. The duration (minutes) and frequency (days) of each activity are questioned. The physical activity levels of the participants will be classified as inactive, minimally active and very active according to the results.
2 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 day
Health Assessment Questionnaire - Disability Index
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Derived from this study: PubMed 35914576Ozturk O, Feyzioglu O, Saritas F. Inflammatory Arthritis Facilitators and Barriers (IFAB) for physical activity questionnaire: cross-cultural adaptation into Turkish and evaluation of its psychometric properties. Disabil Rehabil. 2023 Aug;45(17):2818-2825. doi: 10.1080/09638288.2022.2104940. Epub 2022 Aug 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Axial Spondyloarthritis, run by Acibadem University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Arthritis Barriers and Facilitators to Physical Activity Questionnaire (IFAB) (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019547, which also lists 1 linked publication.
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 29 Dec 2021.