ClinicalTrials.gov record NCT06974942

Physical Activity in Adolescents With Familial Mediterranean Fever

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Investigation of Physical Activity in Adolescents Diagnosed With Familial Mediterranean Fever

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age12 years old to 18 years old
SexAll
LocationTurkey
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational, cross-sectional study compares physical activity, motivation, and activity competence in adolescents with Familial Mediterranean Fever (FMF) and healthy peers. Participants complete standardized questionnaires (including the PAQ-A and two scales of motivation and competence) at one point in time. The study aims to describe activity levels and perceptions to inform planning of exercise programs and future research.

What it is studying. The study is testing how much and what kind of physical activity adolescents with FMF report, and how their motivation and self-rated competence for physical activity compare with healthy peers. It seeks detailed, questionnaire-based measurements to characterize activity behavior and attitudes in this group.

What the researchers hope to learn. To measure and compare physical activity levels, motivation, and competence in adolescents with FMF versus healthy peers; to provide data that can guide planning of exercise programs and support future research in pediatric chronic disease.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • for patients with FMF:
  • 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

Exclusion criteria

  • for patients with FMF:
  • 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
  • Inclusion criteria for healthy peers:
  • Be between 12-18 years of age
  • Be willing to participate in the study
  • Exclusion criteria for healthy peers:
  • 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
  • Exclusion criteria for removal:
  • Leaving at least 3 questions unanswered in the questionnaires

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will complete questionnaires about physical activity, motivation, and competence at baseline using the Adolescent Physical Activity Questionnaire (PAQ-A), the Physical Activity Participation Motivation Scale, and the Physical Activity Competence Scale. No invasive procedures are listed in the registry. Participants may be removed if they leave at least three questionnaire items unanswered. FMF participants remain on their routine medical treatment while taking part.

How the study is structured. Observational, cross-sectional cohort design: two groups (adolescents with FMF and healthy peers) are compared at a single time point using questionnaires (PAQ-A, a motivation scale, and a competence scale). No experimental treatment is assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Turkey. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 15, 2025 (estimated)
Primary completion
Aug 15, 2025 (estimated)
Study completion
Nov 15, 2025 (estimated)
Target enrollment
172 participants (estimated)
Last updated on registry
May 16, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Istanbul University - Cerrahpasa
Principal investigator
Nilay Arman, PhD
Istanbul University - Cerrahpasa

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Istanbul University-Cerrahpasa

    Istanbul · Turkey (Türkiye)

Terms used on this page · explanations by MedicalUpdates.ai

cohort study
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
Inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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