Rheumatic DiseasesNCT06460766
Validity and Reliability of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity Questionnaire
An observational study of Rheumatic Diseases and Pediatric ALL, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
No tool has been found to evaluate behaviors that may hinder or facilitate physical activity in individuals with pediatric rheumatic diseases. In this sense, the importance of examining physical activity barriers and facilitators in children with rheumatic diseases is clear. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Rheumatic Diseases, Pediatric ALL, Children, Only
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2024to Oct 2024
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric rheumatic patients aged 12-18 years who meet the inclusion criteria will be included in our study.
Who may be able to join
- Volunteer
- 12-18 ages
- Diagnosed with juvenile idiopathic arthritis, juvenile dermatomyositis and juvenile fibromyalgia syndrome by a pediatric rheumatologist
- Residing in Turkey
Who cannot join
- Having a vision or hearing problem
- Difficulty adhering to the treatment program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul
Nilay Arman, Asst. Prof.
About this study
Official title: Validity and Reliability of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire for Individuals With Pediatric Rheumatic Disease
No tool has been found to evaluate behaviors that may hinder or facilitate physical activity in individuals with pediatric rheumatic diseases. In this sense, the importance of examining physical activity barriers and facilitators in children with rheumatic diseases is clear. We believe that our study will guide the increase in physical activity, which is very important for reducing disease risks in individuals with pediatric rheumatic diseases. The aim of our study is to examine the validity and reliability of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire in individuals with pediatric rheumatic diseases (juvenile idiopathic arthritis, juvenile fibromyalgia syndrome, juvenile dermatomyositis).
Read the detailed description
Children and adolescents with rheumatic diseases can experience significant disability in both the short and long term due to pain, muscle weakness, fatigue, and restricted joint movement. Exercise training has been noted to potentially benefit individuals with pediatric rheumatic diseases by alleviating various clinical symptoms related to physical disability. In this regard, it is important to routinely assess and monitor physical inactivity and sedentary behaviors, along with examining behaviors that may hinder or facilitate physical activity. However, no tool has been encountered to assess behaviors that may hinder or facilitate physical activity in individuals with pediatric rheumatic disease. In this sense, the importance of examining physical activity barriers and facilitators in children with rheumatic disease is clear. The Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) questionnaire was developed to assess perceived facilitators and barriers to physical activity in patients with inflammatory arthritis. For this purpose, the validity and reliability of the IFAB questionnaire in individuals with pediatric rheumatic diseases (juvenile idiopathic arthritis, juvenile fibromyalgia syndrome, juvenile dermatomyositis) will be examined. Under the supervision of a physical therapist, participants will be assessed using the IFAB questionnaire to evaluate perceived facilitators and barriers to physical activity, the Fear Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA) questionnaire for fear-avoidance beliefs, and the Motivation Scale For Participation In Physical Activity (MSPPA) to measure motivation for physical activity participation. The results of the IFAB questionnaire will be utilized in the validity and reliability analysis, as well as in the analysis of construct validity. For reliability analysis, the IFAB questionnaire will be repeated after 7 days. All forms will be sent to children in Google form format. It is planned to include 70 children in this study. Factor analysis methods will be used in the analysis of the factor structure of the scale, correlation analyses (Pearson and Spearman coefficients) will be used in the analysis of validity and test-retest reliability. Cronbach's alpha analysis will be used in the reliability analysis. The study will be the first to examine physical activity barriers and facilitators in Turkish children with rheumatic disease. The results will contribute to the identification of physical activity barriers and facilitators in Turkish children with rheumatic diseases.
- Conditions
- Rheumatic Diseases, Pediatric ALL, Children, Only
- Keywords
- pediatric rheumatic disease, physical activity, juvenile idiopathic arthritis, juvenile dermatomyositis, juvenile fibromyalgia syndrome
- Medical subject headings
- Rheumatic Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity, Arthritis, Juvenile, Dermatomyositis
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire (Time Frame: Change from baseline to 7 day)
To assess the perceived facilitators and barriers of physical activity in patients with inflammatory arthritis, the IFAB Questionnaire, developed by Davergne et al. The IFAB consists of 10 items measuring factors that either encourage or hinder physical activity. The total score ranges from 70 to 70, a high score indicates a higher level of facilitators and/or a lower level of barriers. In our study, patient's perceived facilitators and barriers to physical activity will be evaluated with IFAB.
Measured: Time Frame: Change from baseline to 7 day
Fear Avoidance Beliefs Questionnaire-Physical Activity (FABQ-PA)
The fear-avoidance beliefs related to physical activity and work effects in low back pain were developed by Waddell et al. The physical activity section consists of 5 questions, with the first question not included in scoring. Each question is evaluated on a scale of 0-6, and patients can score a minimum of 0 and a maximum of 24 points. In our study, patient's fear avoidance beliefs will be evaluated with FABQ-PA.
Measured: Baseline
Motivation Scale For Participation In Physical Activity (MSPPA)
MSPPA was developed by Tekkursun Demir and Cicioglu. It was developed to assess children's motivation to participate in physical activity. The scale, which consists of 16 items, is in the 5-point Likert type. In our study, patient's motivations about physical activity will be evaluated with MSPPA.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Arman, Istanbul University - Cerrahpasa
- Investigators
- Nilay Arman, Asst. Prof., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460766
- Sponsor's protocol ID
- Z651y2FQ
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire for Individuals With Pediatric Rheumatic Disease
- ClinicalTrials.gov ID
- NCT06460766
- Acronym / sponsor ID
- Z651y2FQ
- Conditions
- Rheumatic Diseases, Pediatric ALL, Children, Only
- Keywords
- pediatric rheumatic disease, physical activity, juvenile idiopathic arthritis, juvenile dermatomyositis, juvenile fibromyalgia syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 14 Jun 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.
No tool has been found to evaluate behaviors that may hinder or facilitate physical activity in individuals with pediatric rheumatic diseases. In this sense, the importance of examining physical activity barriers and facilitators in children with rheumatic diseases is clear. We believe that our study will guide the increase in physical activity, which is very important for reducing disease risks in individuals with pediatric rheumatic diseases. The aim of our study is to examine the validity and reliability of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire in individuals with pediatric rheumatic diseases (juvenile idiopathic arthritis, juvenile fibromyalgia syndrome, juvenile dermatomyositis).
Detailed description
Children and adolescents with rheumatic diseases can experience significant disability in both the short and long term due to pain, muscle weakness, fatigue, and restricted joint movement. Exercise training has been noted to potentially benefit individuals with pediatric rheumatic diseases by alleviating various clinical symptoms related to physical disability. In this regard, it is important to routinely assess and monitor physical inactivity and sedentary behaviors, along with examining behaviors that may hinder or facilitate physical activity. However, no tool has been encountered to assess behaviors that may hinder or facilitate physical activity in individuals with pediatric rheumatic disease. In this sense, the importance of examining physical activity barriers and facilitators in children with rheumatic disease is clear. The Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) questionnaire was developed to assess perceived facilitators and barriers to physical activity in patients with inflammatory arthritis. For this purpose, the validity and reliability of the IFAB questionnaire in individuals with pediatric rheumatic diseases (juvenile idiopathic arthritis, juvenile fibromyalgia syndrome, juvenile dermatomyositis) will be examined. Under the supervision of a physical therapist, participants will be assessed using the IFAB questionnaire to evaluate perceived facilitators and barriers to physical activity, the Fear Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA) questionnaire for fear-avoidance beliefs, and the Motivation Scale For Participation In Physical Activity (MSPPA) to measure motivation for physical activity participation. The results of the IFAB questionnaire will be utilized in the validity and reliability analysis, as well as in the analysis of construct validity. For reliability analysis, the IFAB questionnaire will be repeated after 7 days. All forms will be sent to children in Google form format. It is planned to include 70 children in this study. Factor analysis methods will be used in the analysis of the factor structure of the scale, correlation analyses (Pearson and Spearman coefficients) will be used in the analysis of validity and test-retest reliability. Cronbach's alpha analysis will be used in the reliability analysis. The study will be the first to examine physical activity barriers and facilitators in Turkish children with rheumatic disease. The results will contribute to the identification of physical activity barriers and facilitators in Turkish children with rheumatic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric rheumatic patients aged 12-18 years who meet the inclusion criteria will be included in our study.
Key inclusion criteria (4 listed)
- Volunteer
- 12-18 ages
- Diagnosed with juvenile idiopathic arthritis, juvenile dermatomyositis and juvenile fibromyalgia syndrome by a pediatric rheumatologist
- Residing in Turkey
Key exclusion criteria (2 listed)
- Having a vision or hearing problem
- Difficulty adhering to the treatment program
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
Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire (Time Frame: Change from baseline to 7 day)
Time frame: Time Frame: Change from baseline to 7 day
To assess the perceived facilitators and barriers of physical activity in patients with inflammatory arthritis, the IFAB Questionnaire, developed by Davergne et al. The IFAB consists of 10 items measuring factors that either encourage or hinder physical activity. The total score ranges from 70 to 70, a high score indicates a higher level of facilitators and/or a lower level of barriers. In our study, patient's perceived facilitators and barriers to physical activity will be evaluated with IFAB.
Fear Avoidance Beliefs Questionnaire-Physical Activity (FABQ-PA)
Time frame: Baseline
The fear-avoidance beliefs related to physical activity and work effects in low back pain were developed by Waddell et al. The physical activity section consists of 5 questions, with the first question not included in scoring. Each question is evaluated on a scale of 0-6, and patients can score a minimum of 0 and a maximum of 24 points. In our study, patient's fear avoidance beliefs will be evaluated with FABQ-PA.
Motivation Scale For Participation In Physical Activity (MSPPA)
Time frame: Baseline
MSPPA was developed by Tekkursun Demir and Cicioglu. It was developed to assess children's motivation to participate in physical activity. The scale, which consists of 16 items, is in the 5-point Likert type. In our study, patient's motivations about physical activity will be evaluated with MSPPA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
Nilay Arman, Asst. Prof. principal investigator
Istanbul University - Cerrahpasa
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 Rheumatic Diseases and Pediatric ALL, run by Istanbul University - Cerrahpasa 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 2 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 14 Jun 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 Nilay Arman, Asst. Prof. (5534558707, nilayarman@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire (Time Frame: Change from baseline to 7 day) (time frame: Time Frame: Change from baseline to 7 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?
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 14 Jun 2024.