Not Yet RecruitingNot Applicable

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

100 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-Perceived Health-Related Physical Fitness Questionnaire

Timeframe: Until one week after registration

International Fitness Scale

Timeframe: Until one week after the registration date

Trial details

NCT IDNCT07617558

SponsorIstanbul University - Cerrahpasa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-30

Contact for this trial

Nilay Arman, Associate Professor

+90 (553) 455 87 07 nilayarman@iuc.edu.tr

View on ClinicalTrials.gov More Juvenile Idiopathic Arthritis trials