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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06460766
Other study ID # Z651y2FQ
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date October 2024

Study information

Verified date June 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact Nilay Arman, Asst. Prof.
Phone 5534558707
Email nilayarman@iuc.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Volunteer - 12-18 ages - Diagnosed with juvenile idiopathic arthritis, juvenile dermatomyositis and juvenile fibromyalgia syndrome by a pediatric rheumatologist - Residing in Turkey Exclusion Criteria: - Having a vision or hearing problem - Difficulty adhering to the treatment program

Study Design


Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Time Frame: Change from baseline to 7 day
Primary 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. Baseline
Primary 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. Baseline
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