ClinicalTrials.gov record NCT07617558

Validity and Reliability of the International Physical Fitness Questionnaire and the Self-Perceived Health-Related Physical Fitness Questionnaire in Children and Adolescents With JIA and FMF

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

Investigation of the Validity and Reliability of the International Physical Fitness Questionnaire and the Self-Perceived Health-Related Physical Fitness Questionnaire for Children in Children and Adolescents Diagnosed With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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.

Age10 years old to 18 years old

SexAll

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 is a prospective observational study that compares two self‑reported physical‑fitness questionnaires with objective fitness testing in children and adolescents aged 10–18 who have Juvenile Idiopathic Arthritis (JIA) or Familial Mediterranean Fever (FMF). Participants complete the International Fitness Scale and the Self‑Perceived Health‑Related Fitness Questionnaire for Children online and undergo the FitnessGram physical test battery. The study analyzes correlations between questionnaire scores and objective test results and measures the questionnaires' reliability.

What it is studying. The study aims to determine whether the International Fitness Scale (IFS) and the Self‑Perceived Health‑Related Fitness Questionnaire for Children (PHFQ‑C) give valid and reliable measures of physical fitness in young people with JIA or FMF by comparing questionnaire answers with results from the FitnessGram objective tests and by assessing internal consistency and test‑retest reliability.

What the researchers hope to learn. To find out whether these two short, self‑reported questionnaires are valid and reliable tools for assessing physical fitness in children and adolescents with JIA or FMF, and whether they could serve as easier alternatives to longer objective test batteries in clinical or research settings.

What this study is about

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

Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF), two of the most prevalent pediatric rheumatologic diseases, significantly compromise the physical health of children and adolescents, leading to reduced physical fitness, muscle weakness, and a sedentary lifestyle. This study aims to evaluate the validity and reliability of the International Fitness Scale (IFS) and the Self-Perceived Health-Related Fitness Questionnaire for Children (PHFQ-C) as assessment tools for physical fitness in individuals diagnosed with JIA and FMF. Our hypothesis is that these scales will provide demonstrably reliable and valid data within this patient population. To test this, 98 patients aged 10-18 years, recruited from the Pediatric Rheumatology Clinic at Istanbul Faculty of Medicine, will participate. Their physical fitness will be objectively measured using the FitnessGram Test Battery (assessing aerobic capacity, muscular strength, and flexibility), while the IFS and PHFQ-C will be administered online. Statistical analysis, conducted using SPSS 25.0, will employ Pearson/Spearman correlation for validity and Cronbach's alpha and test-retest Intraclass Correlation Coefficient (ICC) for reliability. The expected findings will confirm the utility of the IFS and PHFQ-C as practical, economical, and valid instruments for assessing physical fitness in children and adolescents with JIA/FMF. Promoting the widespread use of these scales in clinical settings will facilitate the rapid and convenient evaluation of patients' fitness levels, thereby enabling the development of early, targeted intervention strategies and ultimately contributing to an improved quality of life. Furthermore, by offering a validated alternative to standard test batteries-which are often cumbersome due to requirements for time, specialized equipment, and expert personnel-this work will make a valuable methodological contribution to the existing scientific literature.

Eligibility

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

Inclusion criteria

Age between 10 and 18 years
Diagnosis of Familial Mediterranean Fever (FMF) or Juvenile Idiopathic Arthritis (JIA) established by a pediatric rheumatologist at least six months prior
Voluntary willingness to participate in the study
Provision of informed consent by both the participant and their parents/guardians
Ability to ambulate independently, communicate effectively, and comply with the instructions required for the research assessments
Sufficient literacy to comprehend written instructions and complete study-related materials

Exclusion criteria

Having a history of a mental or psychological problem that would prevent the understanding of questions or compliance with given instructions.
Medically unstable conditions (history of hospitalization due to heart or lung disease or a disease flare within the 4 weeks prior to the test).
Having a history of a chronic disease of cardiovascular, orthopedic, neuromuscular, or neurological origin that could affect physical fitness.
Having a history of trauma affecting the musculoskeletal system within the last 6 months.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Pediatric rheumatologic diseases are a group of chronic inflammatory conditions that affect multiple organ systems and are characterized by periods of flare-ups. These conditions encompass diverse groups of disorders, including inflammatory arthritis, autoinflammatory syndromes, vasculitis, and other autoimmune diseases. While Juvenile Idiopathic Arthritis (JIA) is the most common rheumatologic disease in childhood and adolescence, Familial Mediterranean Fever (FMF) is another major and frequently encountered rheumatologic condition in the pediatric population in Turkey. FMF is an autosomal recessive autoinflammatory disease, typically manifesting in childhood and presenting with recurrent episodes of fever and pain. JIA is defined as a heterogeneous group of rheumatic inflammatory diseases characterized by arthritis of unknown etiology that begins before the age of 16 and lasts for at least six weeks. These pediatric rheumatologic conditions are often marked by pain, which can lead to limited joint mobility, muscle weakness, and fatigue. Individuals experiencing pain symptoms generally exhibit reduced physical function compared to those who are pain-free. Due to the chronic nature of the disease, frequent attacks, and associated symptoms, individuals with FMF and JIA face significant challenges such as a sedentary lifestyle, physical inactivity, decreased muscle strength, fatigue, low physical fitness, and overall reduced physical function. Several studies have consistently demonstrated low levels of physical fitness in children with JIA and adolescents with FMF. The evaluation of physical fitness in children and adolescents is crucial for identifying developmental differences and allowing for the early detection of potential health problems that may persist into adulthood. While validated and reliable, current physical fitness test batteries frequently encounter practical barriers during field application, including limitations in space, equipment, time constraints, and the need for specialized personnel. These limitations highlight a pressing need for standardized, easily administered scales to facilitate routine clinical assessment.

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 two self-report fitness questionnaires online (the International Fitness Scale and the Self‑Perceived Health‑Related Physical Fitness Questionnaire for Children). They will also perform in-person physical fitness tests from the FitnessGram battery, including the PACER running test, curl-ups, trunk lift, 90° push-ups, back‑saver sit‑and‑reach, and skinfold thickness measurement. All testing and questionnaires are planned to be completed within about one week (target study duration: 7 days).

How the study is structured. A prospective cohort observational study. Enrolled participants complete two self‑report fitness questionnaires online and then perform an objective physical fitness assessment (the FitnessGram battery) over about one week. Researchers will compare questionnaire scores with the objective test results and repeat the questionnaires to check consistency over time.

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?
No sites are listed on the registry yet. Where will the study take place?
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: Jul 1, 2026 (estimated)
Primary completion: Oct 30, 2026 (estimated)
Study completion: Oct 30, 2026 (estimated)
Target enrollment: 100 participants (estimated)
Last updated on registry: Jun 1, 2026
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: Beyza Nur Yumak, PhD Student
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.

Nilay Arman, Associate Professor 📞 +90 (553) 455 87 07 ext. +90 ✉ nilayarman@iuc.edu.tr
Beyza N Yumak, MSc 📞 +90 (539) 856 14 70 ext. +90 ✉ beyzanurymk@gmail.com

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
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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