Juvenile Idiopathic ArthritisNCT07617558
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
An observational study of Juvenile Idiopathic Arthritis and Familial Mediterranean Fever, run by Istanbul University - Cerrahpasa.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Familial Mediterranean Fever
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Oct 2026
- How long will I take part?
- 7 Days
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: It is generally recommended that the sample size for validity and reliability studies be 5 to 10 times the total number of items (30). In light of this information in the literature, and given that the International Physical Fitness Questionnaire (IPFQ) and the Self-Perceived Health-Related Physical Fitness Questionnaire for Children (SPFQ-C) have a total of 14 items, the sample size for our study was determined to be 98 participants. Consequently, we plan to include a minimum of 100 patients diagnosed with JIA or FMF in our study. Participants will be recruited from individuals who are being followed up at the Pediatric Rheumatology Subdivision of the Department of Internal Medical Sciences at Istanbul University Faculty of Medicine and who meet the inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Keywords
- Juvenile Idiopathic Arthritis, Familial Mediterranean Fever, physical fitness, reliability, validity
- Medical subject headings
- Arthritis, Juvenile, Familial Mediterranean Fever
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 |
|---|---|---|
| Patients diagnosed with Juvenile Idiopathic Arthritis or Familial Mediterranean Disease | All participants consist of patients aged 10-18 who are followed by the Istanbul Faculty of Medicine Pediatric Rheumatology Outpatient Clinic and have been diagnosed with Juvenile Idiopathic Arthritis (JIA) or Familial Mediterranean Fever (FMF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Perceived Health-Related Physical Fitness Questionnaire
The scale developed by Fox and Corbin (1989) assesses self-perceived physical fitness based on a four-factor structure, consisting of cardiovascular endurance, muscular flexibility, muscular strength, and body composition (28). Subsequently, a muscular endurance factor was added, yielding the final version of the questionnaire with five dimensions of physical fitness. The instrument comprises two main sections. In the first section, five key components-cardiorespiratory fitness, muscular fitness, flexibility, and body composition-are evaluated using a scale scored from 1 to 5. In the second section, children assess their own physical fitness in comparison with their peers. The total score obtained from the questionnaire ranges from 9 to 45. Except for the body composition item, lower scores on the other items are associated with better physical fitness. In prepubertal Spanish children, ASFU-C exhibited high test-retest reliability and moderate validity across other variables.
Measured: Until one week after registration
International Fitness Scale
The instrument developed by Ortega et al. is a practical self-administered scale designed to assess physical fitness in individuals (24). The scale consists of five domains: overall physical fitness, cardiorespiratory endurance, muscular strength, speed/agility, and flexibility. To examine various components of physical fitness, a five-point Likert scale is employed, ranging from "very good" to "good," "average," "poor," and "very poor." Having been translated into nine different languages, the scale has demonstrated structural reliability and validity across diverse populations, including adolescent cohorts in Brazil, Spain, Colombia, Chile, and several European countries (24, 27).
Measured: Until one week after the registration date
Secondary outcomes (1)
FitnessGram Test Battery
The FitnessGram, developed by the Cooper Institute, is a valid and reliable test battery designed to assess health-related physical fitness. The FitnessGram Test Battery is a comprehensive assessment tool that includes evaluations of aerobic capacity (PACER), body composition (skinfold thickness measurement, body mass index), abdominal muscle strength and endurance (curl-up test), trunk extensor strength and flexibility (trunk lift test), upper extremity muscle strength and endurance (90° push-up test), and flexibility (back-saver sit-and-reach test) (29). In the present study, physical fitness will be assessed using the following components of the FitnessGram Test Battery: the Progressive Aerobic Cardiovascular Endurance Run (PACER), curl-up test, trunk lift test, 90° push-up test, back-saver sit-and-reach test, and skinfold thickness measurement.
The Progressive Aerobic Cardiovascular Endurance Run is a progressive field test recommended for children, adolescents, and adults, condu
Measured: Until one week after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Nur Yumak, Istanbul University - Cerrahpasa
- Investigators
- Nilay Arman, Associate Professor, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617558
- Sponsor's protocol ID
- hXEd9X7x
- Status last verified
- May 2026
- First submitted
- 27 Nov 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07617558
- Acronym / sponsor ID
- hXEd9X7x
- Keywords
- Juvenile Idiopathic Arthritis, Familial Mediterranean Fever, physical fitness, reliability, validity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Jun 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Juvenile Idiopathic Arthritis or Familial Mediterranean Disease | – | –All participants consist of patients aged 10-18 who are followed by the Istanbul Faculty of Medicine Pediatric Rheumatology Outpatient Clinic and have been diagnosed with Juvenile Idiopathic Arthritis (JIA) or Familial Mediterranean Fever (FMF). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- It is generally recommended that the sample size for validity and reliability studies be 5 to 10 times the total number of items (30). In light of this information in the literature, and given that the International Physical Fitness Questionnaire (IPFQ) and the Self-Perceived Health-Related Physical Fitness Questionnaire for Children (SPFQ-C) have a total of 14 items, the sample size for our study was determined to be 98 participants. Consequently, we plan to include a minimum of 100 patients diagnosed with JIA or FMF in our study. Participants will be recruited from individuals who are being followed up at the Pediatric Rheumatology Subdivision of the Department of Internal Medical Sciences at Istanbul University Faculty of Medicine and who meet the inclusion criteria.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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
Self-Perceived Health-Related Physical Fitness Questionnaire
Time frame: Until one week after registration
The scale developed by Fox and Corbin (1989) assesses self-perceived physical fitness based on a four-factor structure, consisting of cardiovascular endurance, muscular flexibility, muscular strength, and body composition (28). Subsequently, a muscular endurance factor was added, yielding the final version of the questionnaire with five dimensions of physical fitness. The instrument comprises two main sections. In the first section, five key components-cardiorespiratory fitness, muscular fitness, flexibility, and body composition-are evaluated using a scale scored from 1 to 5. In the second section, children assess their own physical fitness in comparison with their peers. The total score obtained from the questionnaire ranges from 9 to 45. Except for the body composition item, lower scores on the other items are associated with better physical fitness. In prepubertal Spanish children, ASFU-C exhibited high test-retest reliability and moderate validity across other variables.
International Fitness Scale
Time frame: Until one week after the registration date
The instrument developed by Ortega et al. is a practical self-administered scale designed to assess physical fitness in individuals (24). The scale consists of five domains: overall physical fitness, cardiorespiratory endurance, muscular strength, speed/agility, and flexibility. To examine various components of physical fitness, a five-point Likert scale is employed, ranging from "very good" to "good," "average," "poor," and "very poor." Having been translated into nine different languages, the scale has demonstrated structural reliability and validity across diverse populations, including adolescent cohorts in Brazil, Spain, Colombia, Chile, and several European countries (24, 27).
1 secondary outcome
FitnessGram Test Battery
Time frame: Until one week after registration
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 1 Jun 2026.
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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.
Nilay Arman, Associate Professor study chair
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and Familial Mediterranean Fever, run by Istanbul University - Cerrahpasa.
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 4 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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, Associate Professor (+90 (553) 455 87 07 ext. +90, nilayarman@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Perceived Health-Related Physical Fitness Questionnaire (time frame: Until one week after registration). The study lists 2 primary outcomes in all. 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 1 Jun 2026.