An observational study in Familial Mediterranean Fever (FMF ), sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Istanbul University - Cerrahpasa · Observational
Among 20 studies in Familial Mediterranean Fever with a site in Turkey — 7 open to participants now, 8 under way, none of them phase 3. Familial Mediterranean Fever · Turkey.
Among the 20 studies in Familial Mediterranean Fever with a site in Turkey, this one is the 2nd largest by planned enrollment of the 10 observational ones, is one of 6 that started in 2025, is one of 10 observational ones, and was the 17th registered.
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
This study's planned enrollment of 172 is above the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.
Browse Familial Mediterranean Fever studies →7 of the 20 studies in Familial Mediterranean Fever with a site in Turkey are open now, in 3 countries. Each count lists the studies.
Of the 12 Familial Mediterranean Fever studies recruiting now, 4 (33%) set no upper age limit and 5 (42%) stop at 75 or younger; 10 take children under 18; 3 take healthy volunteers.
This study: 12 Years to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 6 started in 2025.
Median enrollment 60 across the 10 interventional studies, 80 across the 10 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
5 of 20 have an industry lead sponsor. The 10 most frequent:
Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
Istanbul University - Cerrahpasa has 7 studies filed under Familial Mediterranean Fever — fewer than ten, so there is no comparison to draw.
1 of the studies in Familial Mediterranean Fever with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06830213Aysima BarlakInvestigation of the Validity, Reliability and Responsiveness of the BETY-BQ in FMF | 2027-03-30 |
Among the 20 studies in Familial Mediterranean Fever with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
Familial Mediterranean Fever (FMF) is one of the most common autoinflammatory rheumatic diseases in childhood. Problems such as joint pain, muscle weakness, decreased aerobic capacity, and fatigue seen in children and adolescents with rheumatic disease may lead to low physical fitness levels. Limitation of physical performance is one of the possible consequences of chronic diseases that occur during childhood. At the same time, children with chronic illness face many challenges in participating in physical activity. Pediatric patients with rheumatic diseases tend to be physically inactive and, compared to their healthy peers, generally avoid participating in physical activity due to the limitations imposed by the disease. Often, the disease itself paves the way for decreased functional capacity and the development of deconditioning. Therefore, prescribing physical activity and exercise to pediatric populations with chronic illnesses is of great importance. This approach helps alleviate both the symptoms related to chronic diseases and the lifelong complications secondary to pharmacological treatments, and also prevents the development of new chronic conditions.
Participation in adequate physical activity is one of the most important behaviors individuals can adopt to maintain their health and well-being. Globally, public health physical activity guidelines address the exercise needs of children and adolescents. The European Alliance of Associations for Rheumatology (EULAR) highlights in its physical activity and exercise guidelines for patients with rheumatic diseases that the physical activity recommendations made for the general population are also applicable to patients with rheumatic diseases.
With this cohort study, it is aimed to examine physical activity (PA) in detail in adolescents diagnosed with FMF and to compare them with healthy peers. This study is one of the first in our country to provide comprehensive data on the PA levels of adolescents with FMF. The findings obtained will contribute to understanding PA levels and exercise perception, and guide the planning of exercise programs to be developed for these individuals. Moreover, the results of the study may also serve as a basis for future research in children and adolescents with various chronic diseases, especially those with FMF.
Our study consists of two cohorts, where the physical activity level, physical activity competence, and motivation for physical activity of adolescents with Familial Mediterranean Fever (FMF) will be evaluated and compared with their healthy peers.
Inclusion criteria for patients with FMF:
Exclusion criteria for patients with FMF:
Inclusion criteria for healthy peers:
Exclusion criteria for healthy peers:
Exclusion criteria for removal:
The study will include 76 patients diagnosed with Familial Mediterranean Fever who are being followed at the Division of Pediatric Rheumatology, Department of Pediatrics, Istanbul Faculty of Medicine, Istanbul University.
The study will include healthy peers of adolescents diagnosed with FMF.
Adolescent Physical Activity Questionnaire (PAQ-A)
The Adolescent Physical Activity Questionnaire, developed by Kowalski and colleagues in 1997 to assess the physical activity levels of high school students, is an 8-item, 5-point Likert scale tool based on recalling the past 7 days. The 8 items in the scale are used to calculate the physical activity score. The 9th item inquires whether the participant was ill during the past week or if there was any condition preventing normal physical activity. However, this item is not included in the scoring. The first item lists 24 types of physical activity. The frequency of each activity is scored as "never" (1 point), "1-2" (2 points), "3-4" (3 points), "5-6" (4 points), or "7 or more times" (5 points). The result is divided by 24 to obtain the activity score for this item. For items 2-7, responses start with the lowest level of physical activity (1 point) and increase to the highest level (5 points). Item 8 evaluates the frequency of physical activity over the 7 days of the week. Responses a
Time frame: Baseline
Physical Activity Participation Motivation Scale
This scale was developed to assess the motivation of high school students to participate in physical activity. It is a 16-item scale consisting of three factors: individual reasons, environmental reasons, and lack of reasons. In the study, the scale items are rated using a 5-point Likert scale: "Strongly disagree," "Disagree," "Undecided," "Agree," and "Strongly agree." The lowest possible score on the scale is 16, and the highest score is 80. Higher scores indicate more positive motivation to participate in physical activity. In this context, the scores on the Physical Activity Participation Motivation Scale are interpreted as follows: 1-16 indicates very low motivation, 17-32 indicates low motivation, 33-48 indicates medium motivation, 49-64 indicates high motivation, and 65-80 indicates very high motivation for physical activity participation. Items 3, 9, 13, 14, 15, and 16 are reverse-scored. The Cronbach alpha values range from 0.82 to 0.89, indicating good reliability.
Time frame: Baseline
Physical Activity Competence Scale
Physical Activity Competence Scale (PACS), adolescents' physical activity competence in different physical activity areas (at school, in transportation, at home, leisure and recreation, and school-based walking and transportation) is a 5-dimensional and 26-item scale developed to assess their competence. PACS consists of 5 dimensions and 26 items (At school: 6 items, In transportation: 3 items, At home: 5 items, Leisure and recreation: 6 items, School-based walking and transportation: 6 items). The scale form consists of two parts. The first part contains demographic information, and in the second part, participants are asked how confident they are in participating in physical activities in the five physical activity areas. A 10-point Likert-type scale (0 = "I have no confidence" and 100 = "I have full confidence") is used for the items. The total average score is calculated from the answers to the items in each domain and ranges between 0 and 100.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Aug 2025, 3 months later.
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