Familial Mediterranean Fever (FMF )NCT06974942
Physical Activity in Adolescents With Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever (FMF ), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Mediterranean Fever (FMF )
- How many people
- 172 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- Be between 12-18 years of age
- Have been diagnosed with FMF for at least 6 months at the Pediatric Rheumatology Department of Istanbul Faculty of Medicine
- Be undergoing routine medical treatment for FMF
- Be willing to participate in the study
- Be between 12-18 years of age
- Be willing to participate in the study
Who cannot join
- Adolescents whose participation in the study is not wanted by their family
- Having vestibular or neurological balance problems
- Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
- Adolescents with visual or hearing impairments
- Adolescents whose participation in the study is not wanted by their family
- Having vestibular or neurological balance problems
Show all 9Show fewer
- Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
- Adolescents with visual or hearing impairments
- Leaving at least 3 questions unanswered in the questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asya Albayrak, MSc contact
About this study
Official title: Investigation of Physical Activity in Adolescents Diagnosed With Familial Mediterranean Fever
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.
- Conditions
- Familial Mediterranean Fever (FMF )
- Keywords
- Familial Mediterranean Fever, Physical Activity
- Medical subject headings
- Familial Mediterranean Fever, Motor Activity
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 |
|---|---|---|
| Familial Mediterranean Fever | 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. | |
| Healthy control | The study will include healthy peers of adolescents diagnosed with FMF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 May 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies 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
- Cross-sectional
- Enrolment
- 172 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974942
- Sponsor's protocol ID
- paqfmf
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Physical Activity in Adolescents Diagnosed With Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT06974942
- Acronym / sponsor ID
- paqfmf
- Conditions
- Familial Mediterranean Fever (FMF )
- Keywords
- Familial Mediterranean Fever, Physical Activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 16 May 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familial Mediterranean Fever | – | –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. |
| Healthy control | – | –The study will include healthy peers of adolescents diagnosed with FMF. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Be between 12-18 years of age
- Have been diagnosed with FMF for at least 6 months at the Pediatric Rheumatology Department of Istanbul Faculty of Medicine
- Be undergoing routine medical treatment for FMF
- Be willing to participate in the study
- Be between 12-18 years of age
Key exclusion criteria (9 listed)
- Adolescents whose participation in the study is not wanted by their family
- Having vestibular or neurological balance problems
- Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
- Adolescents with visual or hearing impairments
- Adolescents whose participation in the study is not wanted by their family
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
Adolescent Physical Activity Questionnaire (PAQ-A)
Time frame: Baseline
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
2 secondary outcomes
Physical Activity Participation Motivation Scale
Time frame: Baseline
Physical Activity Competence Scale
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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.
Asya Albayrak, MSc contact
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 Familial Mediterranean Fever (FMF ), 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilay Arman, PhD (0553 455 87 07, nilayarman@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Physical Activity Questionnaire (PAQ-A) (time frame: Baseline). 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 16 May 2025.